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1. Kim YH, Kim JS, Choi YH, In KH, Park HS, Hong DS, Jeong TJ, Lee YY, Nam E, Lee SN, Lee KS, Kim HK: Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic or unresectable localized non-small-cell lung cancer. Int J Clin Oncol; 2002 Apr;7(2):114-9
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  • [Title] Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic or unresectable localized non-small-cell lung cancer.
  • BACKGROUND: Docetaxel is highly active in the second-line treatment of patients with metastatic or unresectable locally advanced nonsmall-cell lung cancer (NSCLC).
  • As there is a need for first-line chemotherapy that is more effective than standard platinum-based chemotherapy, this study was undertaken to evaluate the efficacy and tolerability of a docetaxel/cisplatin combination as first-line chemotherapy in advanced NSCLC.
  • METHODS: Newly diagnosed, chemotherapy-naive patients with histologically confirmed NSCLC (measurable stage IIIB/IV NSCLC; Karnofsky performance status, 70-100; adequate bone marrow, renal, hepatic, and cardiac function) were eligible for the study.
  • Histologically, 23 patients (59%) had adenocarcinoma, 12 (30.8%) had squamous cell carcinoma, and 16 patients (41%) had stage IV disease.
  • Median overall survival time in all eligible patients was 10.5 months.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy. Paclitaxel / analogs & derivatives. Taxoids
  • [MeSH-minor] Adult. Aged. Cisplatin / administration & dosage. Female. Hematologic Diseases / chemically induced. Humans. Infusions, Intravenous. Male. Middle Aged. Survival Rate. Treatment Outcome


2. Hirose T, Horichi N, Ohmori T, Shirai T, Sohma S, Yamaoka T, Ohnishi T, Adachi M: Phase I study of the combination of gemcitabine and nedaplatin for treatment of previously untreated advanced non-small cell lung cancer. Lung Cancer; 2003 Jan;39(1):91-7
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  • [Title] Phase I study of the combination of gemcitabine and nedaplatin for treatment of previously untreated advanced non-small cell lung cancer.
  • This trial was conducted to determine the maximum-tolerated dose (MTD), principal toxicity, and recommend dose for phase II study of the combination of gemcitabine and nedaplatin in patients with advanced non-small cell lung cancer (NSCLC).
  • Four patients had stage IIIB disease and 17 patients had stage IV disease.
  • The most common histologic type was adenocarcinoma.
  • Grade 3 hepatic dysfunction occurred in 3 patients.
  • This combination chemotherapy is active and well tolerated and warrants phase II study.
  • [MeSH-major] Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Deoxycytidine / therapeutic use. Lung Neoplasms / drug therapy. Organoplatinum Compounds / administration & dosage. Organoplatinum Compounds / therapeutic use
  • [MeSH-minor] Aged. Drug Therapy, Combination. Female. Humans. Male. Middle Aged. Quality of Life. Survival Rate. Treatment Outcome

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  • (PMID = 12499100.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Journal Article
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 0W860991D6 / Deoxycytidine; 8UQ3W6JXAN / nedaplatin; B76N6SBZ8R / gemcitabine
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3. Agarwala A, Fisher W, Bruetman D, McClean J, Taber D, Titzer M, Juliar B, Yu M, Breen T, Einhorn LH, Hanna N: Gefitinib plus celecoxib in chemotherapy-naïve patients with stage IIIB/IV non-small cell lung cancer: a phase II study from the Hoosier Oncology Group. J Thorac Oncol; 2008 Apr;3(4):374-9
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  • [Title] Gefitinib plus celecoxib in chemotherapy-naïve patients with stage IIIB/IV non-small cell lung cancer: a phase II study from the Hoosier Oncology Group.
  • BACKGROUND: Gefitinib, an inhibitor of the epidermal growth factor receptor (EGFR) pathway, has single agent activity in non-small cell lung cancer (NSCLC).
  • METHODS: chemotherapy-naive, stage IIIb (with pleural effusion) or IV NSCLC, Eastern Cooperative Oncology Group Performance Status (PS) 0-1.
  • Cycles consisted of 21-day treatment and continued until unacceptable toxicity or progression of disease.
  • RESULTS: From January 2004 to November 2004, 31 patients were enrolled: male/female 13/18; median age 70 years (range, 19-93); 68% had adenocarcinoma; Eastern Cooperative Oncology Group PS 0/1 13/18; stage IIIb/IV 2/29.
  • Two patients died of interstitial lung disease due to treatment.
  • There were three additional deaths during treatment that were not considered treatment related.
  • Two additional patients discontinued treatment due to adverse events (elevated liver enzymes).
  • Select grade 3/4 toxicities included: pneumonitis (3%), hepatic (7%), diarrhea (7%), and skin (3%).
  • CONCLUSION: Gefitinib plus celecoxib in an unselected population of chemotherapy naive patients with advanced NSCLC and a PS of 0-1 has a lower response rate and overall efficacy compared with historical controls of combination chemotherapy.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adenocarcinoma / drug therapy. Adenocarcinoma / secondary. Adult. Aged. Aged, 80 and over. Carcinoma, Squamous Cell / drug therapy. Carcinoma, Squamous Cell / secondary. Celecoxib. Disease-Free Survival. Female. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Staging. Pyrazoles / administration & dosage. Quinazolines / administration & dosage. Sulfonamides / administration & dosage. Survival Rate

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  • (PMID = 18379355.001).
  • [ISSN] 1556-1380
  • [Journal-full-title] Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
  • [ISO-abbreviation] J Thorac Oncol
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Pyrazoles; 0 / Quinazolines; 0 / Sulfonamides; JCX84Q7J1L / Celecoxib; S65743JHBS / gefitinib
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4. Kim ES, Lu C, Khuri FR, Tonda M, Glisson BS, Liu D, Jung M, Hong WK, Herbst RS: A phase II study of STEALTH cisplatin (SPI-77) in patients with advanced non-small cell lung cancer. Lung Cancer; 2001 Dec;34(3):427-32
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  • [Title] A phase II study of STEALTH cisplatin (SPI-77) in patients with advanced non-small cell lung cancer.
  • Cisplatin-based chemotherapy improves survival in appropriately selected patients with stage IV non-small cell lung cancer (NSCLC).
  • On the basis of prior preclinical and phase I studies, we initiated a phase II study of SPI-77 (STEALTH) Liposomal Cisplatin) in patients with stage IIIB and IV NSCLC who failed previous treatment with platinum.
  • Disease in all subjects had progressed during therapy, failed to respond, or progressed within 3 months after discontinuing the platinum-based chemotherapy.
  • Patient characteristics included: seven women, six men; median age, 61 years; median Karnofsky performance status, 80%; median number of prior chemotherapy regimens, two (range, 1-3).
  • All patients had adequate hepatic and renal function.
  • These data suggest that this liposomal cisplatin formulation does not have appreciable activity in this population of patients with NSCLC who had received prior platinum-based chemotherapy.
  • [MeSH-major] Carcinoma, Non-Small-Cell Lung / drug therapy. Cisplatin / therapeutic use. Lung Neoplasms / drug therapy
  • [MeSH-minor] Disease Progression. Female. Humans. Liposomes. Male. Middle Aged. Survival Rate. Treatment Outcome


5. Katakami N, Sugiura T, Nogami T, Yamamoto H, Negoro S, Nakano T, Okamoto N, Takada Y, Kodama K, Ariyoshi Y: Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB-IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908. Lung Cancer; 2004 Jan;43(1):93-100
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  • [Title] Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB-IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908.
  • OBJECTIVES: Vinorelbine (V) and gemcitabine (G) are two active single agents used in the treatment of non-small cell lung cancer (NSCLC).
  • METHODS: no previous chemotherapy; performance status (PS) 0 or 1; age <75 years old.
  • Baseline characteristics: median age 60, males 30 (60%), Eastern Cooperative Oncology Group (ECOG) PS 0/1=21/29 (58%), stage IIIB/IV=12/38 (76%), adenocarcinoma=35 (70%).
  • Grade III/IV toxicities were as follows: neutropenia grade III/IV=66%, anemia grade III/IV=16%, thrombocytopenia grade III/IV=2%, nausea grade III/IV=10%, vomiting grade III/IV=0%, documented infection grade III/IV=10%, skin rash grade III/IV=2%, and hepatic grade III/IV=8%.
  • There were no treatment-related deaths.
  • The median time to progression was 4.1 months.
  • The overall median survival time (MST) was 13.9 months (range, 2.4 to >16.2 months) with a median follow-up time of 13.9 months.
  • The MST for stage IIIB and stage IV was >14.5 and 12.7 months, respectively.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / analogs & derivatives. Lung Neoplasms / drug therapy. Vinblastine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Female. Humans. Infusions, Intravenous. Japan. Male. Middle Aged. Neoplasm Staging. Survival Analysis. Treatment Outcome

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  • [CommentIn] Lung Cancer. 2004 Dec;46(3):377-8 [15541824.001]
  • (PMID = 14698543.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; 5V9KLZ54CY / Vinblastine; B76N6SBZ8R / gemcitabine; Q6C979R91Y / vinorelbine
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6. Hirose T, Sugiyama T, Kusumoto S, Shirai T, Nakashima M, Yamaoka T, Okuda K, Ogura K, Ohnishi T, Ohmori T, Adachi M: Phase II study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer. Anticancer Res; 2009 May;29(5):1733-8
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  • [Title] Phase II study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer.
  • BACKGROUND: To date, no phase II trial of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) has been published.
  • PATIENTS AND METHODS: Patients with previously untreated NSCLC, either stage IIIB with pleural effusion or stage IV, were eligible if they had a performance status of 0 to 2, were 75 years or younger and had adequate organ function.
  • The median survival time was 13 months (range, 1 to 36 months), the 1-year survival rate was 62% and the median time to disease progression was 5 months (range, 1 to 19 months).
  • Although frequent non-hematologic toxicities were nausea, hepatic dysfunction and peripheral neuropathy, all cases were of only mild to moderate severity.
  • Although 1 patient had grade 3 pulmonary toxicity due to drug-induced pneumonia, this patient recovered after receiving steroid therapy.
  • CONCLUSION: This combination chemotherapy is effective and well tolerated and is an acceptable therapeutic option for patients with untreated advanced NSCLC.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy

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  • (PMID = 19443395.001).
  • [ISSN] 0250-7005
  • [Journal-full-title] Anticancer research
  • [ISO-abbreviation] Anticancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 8UQ3W6JXAN / nedaplatin; P88XT4IS4D / Paclitaxel
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7. Mok TS, Zee B, Chan AT, Yeo W, Yang WT, Yim A, Leung SF, Nguyen B, Leung TW, Johnson P: A phase II study of gemcitabine plus oral etoposide in the treatment of patients with advanced nonsmall cell lung carcinoma. Cancer; 2000 Aug 1;89(3):543-50
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  • [Title] A phase II study of gemcitabine plus oral etoposide in the treatment of patients with advanced nonsmall cell lung carcinoma.
  • BACKGROUND: The authors have designed a non-cisplatin-based chemotherapy regimen for the treatment of patients with advanced nonsmall cell lung carcinoma (NSCLC).
  • METHODS: A total of 46 chemotherapy-naive patients with histologically confirmed Stage IIIB or IV NSCLC were enrolled.
  • The median time to progression for all patients was 39.2 weeks (95% CI, 35.7-49.7 weeks).
  • Two patients had reactivation of hepatitis B viral infection that resulted in WHO Grade 4 hepatic dysfunction.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Etoposide / administration & dosage. Lung Neoplasms / drug therapy

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  • [Copyright] Copyright 2000 American Cancer Society.
  • (PMID = 10931453.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; 6PLQ3CP4P3 / Etoposide; B76N6SBZ8R / gemcitabine
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8. Crinò L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C: Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol; 2010 Aug;11(8):733-40
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  • [Title] Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study.
  • BACKGROUND: Results of two phase 3 trials have shown first-line bevacizumab in combination with chemotherapy improves clinical outcomes in patients with advanced or recurrent non-squamous non-small-cell lung cancer (NSCLC).
  • The SAiL (MO19390) study was undertaken to assess the safety and efficacy of first-line bevacizumab combined with standard chemotherapy regimens in clinical practice.
  • Eligible patients had histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent disease (stage IIIB-IV); an Eastern Cooperative Oncology Group performance status of 0-2; and adequate haematological, hepatic, and renal function.
  • Patients received bevacizumab (7.5 or 15 mg/kg every 3 weeks) plus standard chemotherapy for up to six cycles, followed by single-agent bevacizumab until disease progression.
  • INTERPRETATION: Our results confirm the manageable safety profile of first-line bevacizumab in combination with various standard chemotherapy regimens for treatment of advanced non-squamous NSCLC.
  • [MeSH-major] Angiogenesis Inhibitors / therapeutic use. Antibodies, Monoclonal / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal, Humanized. Antineoplastic Combined Chemotherapy Protocols. Bevacizumab. Drug-Related Side Effects and Adverse Reactions. Female. Humans. Intention to Treat Analysis. Male. Middle Aged. Survival Analysis

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  • [Copyright] 2010 Elsevier Ltd. All rights reserved.
  • [CommentIn] Lancet Oncol. 2010 Aug;11(8):703-4 [20650687.001]
  • (PMID = 20650686.001).
  • [ISSN] 1474-5488
  • [Journal-full-title] The Lancet. Oncology
  • [ISO-abbreviation] Lancet Oncol.
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00451906
  • [Publication-type] Clinical Trial, Phase IV; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 2S9ZZM9Q9V / Bevacizumab
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9. Takayama K, Kawasaki M, Ninomiya K, Motohiro A, Fujita M, Watanabe K, Kajiki A, Iwami F, Miyazaki N, Izumi M, Hara N, Nakanishi Y, Fukuoka Lung Cancer Study Group, Japan: Phase II study of uracil-tegafur plus cisplatin in patients with previously untreated advanced non-small cell lung cancer. Respirology; 2008 Jan;13(1):103-7
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  • [Title] Phase II study of uracil-tegafur plus cisplatin in patients with previously untreated advanced non-small cell lung cancer.
  • BACKGROUND AND OBJECTIVE: A multi-institutional phase II trial combining uracil-tegafur (UFT) and cisplatin (CDDP) was conducted in patients with previously untreated advanced non-small cell lung cancer (NSCLC) to evaluate the safety and efficacy of this combined treatment regimen.
  • METHODS: The entry criteria for this study were previously untreated NSCLC, measurable disease, age <80 years, performance status <2, and adequate haematological, hepatic and renal function.
  • The treatment course was repeated every 3 weeks.
  • RESULTS: Of the 68 patients enrolled, 64 (27 with stage IIIB and 37 with stage IV disease) were eligible for treatment.
  • Twenty of the 64 patients responded to the chemotherapy (response rate 31.3%; 95% CI 21.2-43.4%).
  • The median survival time was 8.6 months, and the 1-year survival was 41.5%.
  • CONCLUSIONS: The combination of oral UFT plus cisplatin was found to be a safe and active treatment against advanced NSCLC.
  • The observed low toxicity of this combined regimen may warrant its application to the treatment of elderly patients.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adult. Age Factors. Aged. Cisplatin / administration & dosage. Cisplatin / adverse effects. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Humans. Male. Middle Aged. Neoplasm Staging. Survival Rate. Tegafur / administration & dosage. Tegafur / adverse effects. Treatment Outcome. Uracil / administration & dosage. Uracil / adverse effects

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  • (PMID = 18197918.001).
  • [ISSN] 1440-1843
  • [Journal-full-title] Respirology (Carlton, Vic.)
  • [ISO-abbreviation] Respirology
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] Australia
  • [Chemical-registry-number] 1548R74NSZ / Tegafur; 56HH86ZVCT / Uracil; Q20Q21Q62J / Cisplatin; FP protocol
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10. Adachi S, Ogasawara T, Tsubamoto H, Oku H, Hori Y, Tsuji Y, Takemura T, Koyama K: Intravenous nedaplatin and intraarterial cisplatin with transcatheter arterial embolization for patients with locally advanced uterine cervical cancer. Int J Clin Pharmacol Res; 2001;21(3-4):105-10
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  • [Title] Intravenous nedaplatin and intraarterial cisplatin with transcatheter arterial embolization for patients with locally advanced uterine cervical cancer.
  • Nedaplatin is a platinum analog that has less renal toxicity and higher efficacy for uterine cervical cancer than cisplatin.
  • Intraarterial cisplatin has been shown to be more effective than intravenous cisplatin in the treatment of cervical cancer.
  • To improve the prognosis of cervical cancer, we studied combination chemotherapy of intravenous nedaplatin and intraarticular cisplatin with transcatheter arterial embolization (TAE).
  • The criteria for selecting patients for this study were as follows: age 16-75 years, stage Ib2-IV according to the classification of the International Federation of Gynecology and Obstetrics (FIGO), performance status between 0 and 2, a creatinine clearance of >40 ml/min, adequate bone marrow and adequate renal and hepatic function.
  • FIGO stage was Ib2 in seven patients, IIa in seven patients, IIb in four, IIIa in one, IIIb in seven and IVa in six.
  • This course of treatment was repeated every 3 weeks for 2-3 cycles.
  • Response to the therapy was defined by magnetic resonance imaging.
  • These results show that this combination chemotherapy effected a high response rate.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Balloon Occlusion / methods. Cisplatin / administration & dosage. Organoplatinum Compounds / administration & dosage. Uterine Cervical Neoplasms / drug therapy. Uterine Neoplasms / drug therapy
  • [MeSH-minor] Adenocarcinoma / drug therapy. Adenocarcinoma / mortality. Adult. Aged. Antineoplastic Agents / administration & dosage. Carcinoma, Adenosquamous / drug therapy. Carcinoma, Adenosquamous / mortality. Carcinoma, Squamous Cell / drug therapy. Carcinoma, Squamous Cell / mortality. Female. Follow-Up Studies. Humans. Infusions, Intra-Arterial. Infusions, Intravenous. Middle Aged. Survival Rate

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  • (PMID = 12067139.001).
  • [ISSN] 0251-1649
  • [Journal-full-title] International journal of clinical pharmacology research
  • [ISO-abbreviation] Int J Clin Pharmacol Res
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Organoplatinum Compounds; 8UQ3W6JXAN / nedaplatin; Q20Q21Q62J / Cisplatin
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11. Gridelli C, Cigolari S, Maiorino A, Ianniello GP, Brancaccio L, Rossi A, De Cataldis G, Pedicini T, Maiorino L, Barletta E, Di Lanno M, Bilancia D, Crispino C, Barzelloni ML, Masullo P, D'Aniello R, Manzione L: Amifostine plus cisplatin plus vinorelbine in the treatment of advanced non small cell lung cancer: a multicenter phase II study. Lung Cancer; 2000 Jun;28(3):237-44
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  • [Title] Amifostine plus cisplatin plus vinorelbine in the treatment of advanced non small cell lung cancer: a multicenter phase II study.
  • PURPOSE: to evaluate the activity and toxicity of the combination cisplatin plus vinorelbine plus amifostine in advanced non small cell lung cancer (NSCLC).
  • PATIENTS AND METHODS: a two-stage Simon design was applied.
  • To proceed after the first stage, responses from seven of 19 patients were needed.
  • Inclusion criteria were cyto-histologically proven stage IIIB-IV NSCLC; age of 70 years or less; Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; normal cardiac, hepatic, renal and bone marrow functions; and no previous chemotherapy.
  • Eleven of 40 enrolled patients were stage IIIB and 29 stage IV, with a median age of 57 years (range, 38-70 years).
  • Median time to progression was 20 weeks, and median survival was 45 weeks.
  • CONCLUSION: these data show that cisplatin plus vinorelbine plus amifostine is an active and feaseable regimen in stage IIIB-IV NSCLC.
  • A phase III trial comparing cisplatin plus vinorelbine versus cisplatin plus vinorelbine plus amifostine in advanced NSCLC is warranted.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Amifostine / administration & dosage. Amifostine / therapeutic use. Cisplatin / administration & dosage. Cisplatin / therapeutic use. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Neoplasm Staging. Survival Rate. Tomography, X-Ray Computed. Treatment Outcome. Vinblastine / administration & dosage. Vinblastine / therapeutic use

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  • (PMID = 10812192.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] IRELAND
  • [Chemical-registry-number] 5V9KLZ54CY / Vinblastine; M487QF2F4V / Amifostine; Q20Q21Q62J / Cisplatin; ACV protocol
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12. Camps C, Martínez EN, Jaime AB: Second-line treatment with gemcitabine and vinorelbine in non-small-cell lung cancer (NSCLC) cisplatin failures: a pilot study. Lung Cancer; 2000 Jan;27(1):47-53
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  • [Title] Second-line treatment with gemcitabine and vinorelbine in non-small-cell lung cancer (NSCLC) cisplatin failures: a pilot study.
  • PURPOSE: This pilot study was designed to evaluate the efficacy and toxicity of the gemcitabine/vinorelbine combination in non-small-cell lung cancer (NSCLC) patients who had failed cisplatin-based first-line chemotherapy.
  • PATIENTS AND METHODS: Eligible patients had refractory or resistant NSCLC, WHO performance status 0-2, adequate hematologic parameters and normal hepatic, renal and cardiac function.
  • RESULTS: From September 1997 to March 1998, 16 patients were enrolled (six: stage IIIB: ten: stage IV).
  • There were seven (13.20%) episodes of fever related to the drug administration.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy. Neoplasm Recurrence, Local / drug therapy
  • [MeSH-minor] Adult. Aged. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Female. Humans. Male. Middle Aged. Neutropenia / chemically induced. Pilot Projects. Thrombocytopenia / chemically induced. Treatment Outcome. Vinblastine / administration & dosage. Vinblastine / analogs & derivatives

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  • [ErratumIn] Lung Cancer 2000 Sep;29(3):227. Herrero, CC [corrected to Camps, C]
  • (PMID = 10672783.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] IRELAND
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; 5V9KLZ54CY / Vinblastine; B76N6SBZ8R / gemcitabine; Q6C979R91Y / vinorelbine
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13. Paciucci PA, Raptis G, Bleiweiss I, Weltz C, Lehrer D, Gurry R: Neo-adjuvant therapy with dose-dense docetaxel plus short-term filgrastim rescue for locally advanced breast cancer. Anticancer Drugs; 2002 Sep;13(8):791-5
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  • [Title] Neo-adjuvant therapy with dose-dense docetaxel plus short-term filgrastim rescue for locally advanced breast cancer.
  • Neo-adjuvant, dose-dense docetaxel, 100 mg/m(2) every 2 weeks x 4 cycles, was administered to 12 patients with locally advance breast cancer (LABC) (10 stage IIIa and three stage IIIb).
  • Eligibility requirements included a PS 0-2, normal hepatic and renal function, and radiologic absence of metastatic disease.
  • Filgrastim [granulocyte colony stimulating factor (G-CSF)] was started 1 day after chemotherapy and was given for 6 days.
  • The median age was 45 (range 34-73) and pre-treatment pathology revealed poorly differentiated infiltrating duct carcinoma in 11 and infiltrating lobular cancer in one, with positive ER/PR status in five.
  • Three patients (of whom two with stage IIIb) had progressive disease and went on to receive neo-adjuvant therapy with AC.
  • There were two instances of grade 3 extra-hematologic toxicity: one patient had severe pain and one had treatment-related fatigue.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Breast Neoplasms / drug therapy. Granulocyte Colony-Stimulating Factor / administration & dosage. Paclitaxel / administration & dosage. Paclitaxel / analogs & derivatives. Taxoids
  • [MeSH-minor] Adult. Aged. Female. Filgrastim. Humans. Middle Aged. Neoadjuvant Therapy. Recombinant Proteins

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  • (PMID = 12394262.001).
  • [ISSN] 0959-4973
  • [Journal-full-title] Anti-cancer drugs
  • [ISO-abbreviation] Anticancer Drugs
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Recombinant Proteins; 0 / Taxoids; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 15H5577CQD / docetaxel; P88XT4IS4D / Paclitaxel; PVI5M0M1GW / Filgrastim
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14. Fornasiero A, Ghiotto C, Daniele O, Favaretto AG, D'Amanzo P, Ziade A: Neoadjuvant moderately high-dose chemotherapy with rh-G-CSF in locally advanced breast carcinoma. Tumori; 2001 Jul-Aug;87(4):223-8
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  • [Title] Neoadjuvant moderately high-dose chemotherapy with rh-G-CSF in locally advanced breast carcinoma.
  • The poor results of local treatment for locally advanced breast carcinoma (LABC) justify the use of chemotherapy as primary treatment.
  • Retrospective studies have shown a positive correlation between dose and response rate in advanced breast cancer.
  • G-CSF has shown efficacy in achieving optimal dose intensity and ameliorating chemotherapy-induced myelosuppression.
  • The aim of the present study was to assess the efficacy of a moderately high-dose chemotherapy regimen in terms of response rate, disease-free and overall survival and to assess the role of G-CSF in induced neutropenia.
  • METHODS: Inclusion criteria were the following: age <65 years, WHO performance status <2, histologically proven breast carcinoma, adequate hematologic, renal and hepatic function, stage IIIA or IIIB disease, and no metastatic disease.
  • No prior chemotherapy or radiotherapy was allowed.
  • Three cycles of the following chemotherapy were used preoperatively: epirubicin (100 mg/m2 on day 1), cyclophosphamide (400 mg/m2 for 3 consecutive days) and rh-G-CSF (5 microg/kg/die from day 4 to day 12 every 14 days).
  • After mastectomy or quadrantectomy plus radiotherapy, all patients were treated with 4 courses of adjuvant chemotherapy according to the CMF 1-8 schedule (methotrexate, 40 mg/m2 cyclophosphamide, 600 mg/m2; fluorouracil, 600 mg/m2; all on days 1 and 8, with recycle every 4 weeks).
  • Thirty-five patients had stage IIIA and 22 patients stage IIIB disease (7 with inflammatory disease).
  • The overall 5-year survival rate was 76% (standard error--SE), 6%) and the 5-year disease-free survival rate was 68% (SE, 6.3%).
  • CONCLUSIONS: The 14-day regimen was well tolerated and effective in LABC patients, although not superior to standard-dose chemotherapy.
  • To improve results the use of new drugs in controlled clinical trials seems warranted.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Breast Neoplasms / drug therapy. Granulocyte Colony-Stimulating Factor / therapeutic use. Neutropenia / drug therapy
  • [MeSH-minor] Adult. Chemotherapy, Adjuvant. Cyclophosphamide / administration & dosage. Cyclophosphamide / therapeutic use. Female. Filgrastim. Fluorouracil / administration & dosage. Fluorouracil / therapeutic use. Humans. Methotrexate / administration & dosage. Methotrexate / therapeutic use. Middle Aged. Recombinant Proteins

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  • (PMID = 11693799.001).
  • [ISSN] 0300-8916
  • [Journal-full-title] Tumori
  • [ISO-abbreviation] Tumori
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Recombinant Proteins; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 8N3DW7272P / Cyclophosphamide; PVI5M0M1GW / Filgrastim; U3P01618RT / Fluorouracil; YL5FZ2Y5U1 / Methotrexate; CMF regimen
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15. Passardi A, Massa I, Zoli W, Gianni L, Milandri C, Zumaglini F, Nanni O, Maltoni R, Frassineti GL, Amadori D: Phase II study of gemcitabine, doxorubicin and paclitaxel (GAT) as first-line chemotherapy for metastatic breast cancer: a translational research experience. BMC Cancer; 2006;6:76
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  • [Title] Phase II study of gemcitabine, doxorubicin and paclitaxel (GAT) as first-line chemotherapy for metastatic breast cancer: a translational research experience.
  • BACKGROUND: Patients with metastatic breast cancer are frequently treated with anthracyclines and taxanes, which are among the most active agents in this disease.
  • Gemcitabine is an interesting candidate for a three-drug combination because of its different mechanism of action and non-overlapping toxicity with respect to the other two drugs.
  • We aimed to evaluate the activity and toxicity of the GAT (gemcitabine, doxorubicin and paclitaxel) regimen, derived from experimental preclinical studies, as first-line chemotherapy in patients with stage IIIB-IV breast cancer.
  • METHODS: Patients with locally advanced or metastatic breast cancer and at least one bidimensionally measurable lesion were included in the present study.
  • Adequate bone marrow reserve, normal cardiac, hepatic and renal function, and an ECOG performance status of 0 to 2 were required.
  • Only prior adjuvant non anthracycline-based chemotherapy was permitted.
  • Treatment consisted of doxorubicin 50 mg/m2 on day 1, paclitaxel 160 mg/m2 on day 2 and gemcitabine 800 mg/m2 on day 6, repeated every 21-28 days.
  • RESULTS: Thirty-three consecutive breast cancer patients were enrolled onto the trial (7 stage IIIB and 26 stage IV).
  • Median time to progression and overall survival were 10.2 and 36.4 months, respectively.
  • The most important toxicity was hematological, with grade III-IV neutropenia observed in 69% of patients, sometimes requiring the use of granulocyte colony-stimulating factor (27%).
  • One patient died from sepsis during the first treatment cycle before the administration of gemcitabine.
  • CONCLUSION: The strong synergism among the three drugs found in the preclinical setting was confirmed in terms of both clinical activity and hematological toxicity.
  • Our results seem to indicate that the GAT regimen is effective in anthracycline-naïve metastatic breast cancer and provides a feasible chemotherapeutic option in this clinical setting.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Breast Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Disease Progression. Doxorubicin / administration & dosage. Female. Humans. Infusions, Intravenous. Middle Aged. Neoplasm Metastasis. Paclitaxel / administration & dosage. Survival Analysis. Treatment Outcome

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  • (PMID = 16551351.001).
  • [ISSN] 1471-2407
  • [Journal-full-title] BMC cancer
  • [ISO-abbreviation] BMC Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; 80168379AG / Doxorubicin; B76N6SBZ8R / gemcitabine; P88XT4IS4D / Paclitaxel
  • [Other-IDs] NLM/ PMC1434761
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16. Kosmidis P, Mylonakis N, Skarlos D, Samantas E, Dimopoulos M, Papadimitriou C, Kalophonos C, Pavlidis N, Nikolaidis C, Papaconstantinou C, Fountzilas G: Paclitaxel (175 mg/m2) plus carboplatin (6 AUC) versus paclitaxel (225 mg/m2) plus carboplatin (6 AUC) in advanced non-small-cell lung cancer (NSCLC): a multicenter randomized trial. Hellenic Cooperative Oncology Group (HeCOG). Ann Oncol; 2000 Jul;11(7):799-805
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  • [Title] Paclitaxel (175 mg/m2) plus carboplatin (6 AUC) versus paclitaxel (225 mg/m2) plus carboplatin (6 AUC) in advanced non-small-cell lung cancer (NSCLC): a multicenter randomized trial. Hellenic Cooperative Oncology Group (HeCOG).
  • PATIENTS AND METHODS: Since July 1996, 198 patients with non-operable NSCLC and measurable disease without previous chemotherapy entered the trial.
  • Ninety nine patients (group A) were randomized to receive paclitaxel 175 mg/m2 in three-hour infusion plus carboplatin dosed to an area under the concentration-time curve of 6 every 3 weeks and 99 (group B) to receive the same regimen with paclitaxel increased to 225 mg/m2.
  • Eligibility criteria included WHO performance status 0-2, documented inoperable stage IIIA and IIIB, IV, no brain metastasis, no prior chemotherapy and adequate renal and hepatic function.
  • RESULTS: In group A with 90 evaluable patients, the response rate was 25.6% (6 CR, 17 PR) whereas in group B with 88 evaluable patients, the response rate was 31.8% (3 CR, 25 PR), P = 0.733.
  • Median time to progression favored the high-dose paclitaxel (4.3 vs. 6.4 months, P = 0.044).
  • CONCLUSIONS: Higher dose paclitaxel prolongs the median time to progression but causes more neurotoxicity and leucopenia.

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  • (PMID = 10997806.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] BG3F62OND5 / Carboplatin; P88XT4IS4D / Paclitaxel
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17. Nasu K, Umekita N, Noda K, Tanaka S, Maeshiro T, Miyamoto S, Inoue S, Arai K: [A case of recurrent colon cancer patient who gained a long-term survival by repeated and aggressive surgical resection]. Gan To Kagaku Ryoho; 2008 Nov;35(12):2150-2
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  • [Title] [A case of recurrent colon cancer patient who gained a long-term survival by repeated and aggressive surgical resection].
  • We performed right hemicolectomy with liver S7 partial excision (a postoperative diagnosis of the hepatic lesion, adenoma) for ascending colon carcinoma of type 2 with hepatic metastasis.
  • Postoperative diagnosis was ss, n2, ly2, v2, Stage IIIb, based on the Japanese classification of colon cancer.
  • Twelve months after the first operation, she was developed intestinal atresia by an abdominal wall recurrence, and we performed the operation of abdominal wall mass resection with a partial resection of small bowel.
  • Afterwards she developed a recurrence three times in the abdominal wall or intra-abdominal lymph nodes during the next 1 year and six months, and we performed a local excision each time.
  • After the final operation, we did not perform chemotherapy because the patient wished not to have it.
  • Recently, the therapy for recurrent colon cancer has been shifted to more effective chemotherapy such as FOLFOX or FOLFIRI regimen, and a surgical resection is becoming rare.
  • However, we experienced a case of recurrent colon cancer treated with four aggressive surgical resections that was beneficial for a long-term survival.
  • [MeSH-minor] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Female. Humans. Liver Neoplasms / secondary. Liver Neoplasms / surgery. Lymphatic Metastasis. Middle Aged. Positron-Emission Tomography. Time Factors. Tomography, X-Ray Computed

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  • (PMID = 19106553.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Japan
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18. Zarogoulidis K, Kontakiotis T, Hatziapostolou P, Fachantidou E, Delis D, Goutsikas J, Constantinidis TC, Athanasiadis A, Patakas D: A Phase II study of docetaxel and carboplatin in the treatment of non-small cell lung cancer. Lung Cancer; 2001 Jun;32(3):281-7
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  • [Title] A Phase II study of docetaxel and carboplatin in the treatment of non-small cell lung cancer.
  • We investigated the efficacy of docetaxel (D) in combination with carboplatin (C) in the treatment of non-small cell lung cancer (NSCLC) patients.
  • Eligibility criteria included, documented inoperable NSCLC, WHO performance status (PS) 0-1, age up to 70 years, and normal renal and hepatic function.
  • A total of 622 cycles of chemotherapy (CHT) (median 7 (95% CI 6.2-7.47), courses per patient) were administered.
  • Each cycle consisted of 100 mg/m(2) of docetaxel in a 2-h infusion with C at a dose of area under the curve (AUC) of 6 on day 1.
  • The median survival was 12 months for all patients, 12 for the four patients with stage IIb disease, 18 for the patients with stage IIIa disease, 20 for the 29 patients with stage IIIb disease, and 11 for the 65 stage IV patients.
  • The median time to progression was 8 months (90 patients).
  • Responders received radiotherapy (total dose, 50 Gy in 4 weeks) between the 6th and 8th cycle.
  • Among responders with initial stage IIIb disease, 7 (5%) underwent surgical resection.
  • Preliminary results indicate that the D/C combination is very active in the treatment of NSCLC with tolerable toxicity.
  • It appears that this drug combination is also good as neoadjuvant therapy in inoperable NSCLC patients.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy. Paclitaxel / analogs & derivatives. Taxoids
  • [MeSH-minor] Adult. Aged. Anemia / chemically induced. Carboplatin / administration & dosage. Disease Progression. Disease-Free Survival. Female. Humans. Male. Middle Aged. Neoadjuvant Therapy. Neutropenia / chemically induced. Treatment Outcome

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  • (PMID = 11390009.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Taxoids; 15H5577CQD / docetaxel; BG3F62OND5 / Carboplatin; P88XT4IS4D / Paclitaxel
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19. Greco FA, Bonomi P, Crawford J, Kelly K, Oh Y, Halpern W, Lo L, Gallant G, Klein J: Phase 2 study of mapatumumab, a fully human agonistic monoclonal antibody which targets and activates the TRAIL receptor-1, in patients with advanced non-small cell lung cancer. Lung Cancer; 2008 Jul;61(1):82-90
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  • [Title] Phase 2 study of mapatumumab, a fully human agonistic monoclonal antibody which targets and activates the TRAIL receptor-1, in patients with advanced non-small cell lung cancer.
  • BACKGROUND: Preclinical pharmacological properties of mapatumumab (agonistic human monoclonal antibody to TRAIL-R1) suggest that this antibody reduces cell viability, induces cell death in many types of cancer cell lines in vitro, inhibits or reduces tumor growth in xenograft models of solid tumors, and can induce significant tumor regression in some models.
  • This pharmacologic profile suggests that mapatumumab may have therapeutic benefit in the treatment of NSCLC.
  • METHODS: This Phase 2 multi-center study was designed to evaluate the efficacy, safety, and tolerability of mapatumumab in patients with advanced non-small cell lung cancer (NSCLC) previously treated with at least 1 platinum-based regimen.
  • RESULTS: A total of 32 patients with relapsed or refractory Stage IIIB or IV or recurrent NSCLC were enrolled.
  • Patients had received a median of 3 previous therapeutic regimens (range 1-7).
  • Laboratory analyses revealed no appreciable evidence of hepatic or renal toxicity among the study patients.
  • No patients developed anti-mapatumumab antibodies.
  • CONCLUSION: In a group of heavily pretreated NSCLC patients, no objective single agent activity of mapatumumab was demonstrated, but the drug was safe and well tolerated.
  • Based on this favorable safety profile, and preclinical evidence of potential synergy in combination with agents commonly used to treat NSCLC, future evaluation of mapatumumab in combination with chemotherapy is warranted.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antineoplastic Agents / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy. Receptors, Tumor Necrosis Factor / metabolism

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  • (PMID = 18255187.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antineoplastic Agents; 0 / Receptors, TNF-Related Apoptosis-Inducing Ligand; 0 / Receptors, Tumor Necrosis Factor; 0 / TNFRSF10A protein, human; 0 / mapatumumab
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20. Kiura K, Takigawa N, Segawa Y, Tabata M, Shibayama T, Gemba K, Bessho A, Fujimoto N, Takata I, Hotta K, Fujiwara K, Tokuda Y, Kuyama S, Shinkai T, Ueoka H, Tanimoto M, Okayama Lung Cancer Study Group: Triple combination chemotherapy with cisplatin, docetaxel, and irinotecan for advanced non-small cell lung cancer: a phase I/II trial. J Thorac Oncol; 2007 Jan;2(1):44-50
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  • [Title] Triple combination chemotherapy with cisplatin, docetaxel, and irinotecan for advanced non-small cell lung cancer: a phase I/II trial.
  • BACKGROUND: To determine the recommended dose and evaluate the response rate and toxicity of triplet chemotherapy using cisplatin, docetaxel, and irinotecan for non-small cell lung cancer (NSCLC) patients with stage IIIB or IV.
  • Most patients had performance status 1 (49/65) and stage IV disease (49/65).
  • In the phase II study, 157 cycles of chemotherapy were delivered to 49 patients (median three cycles per patient).
  • The median survival time and the actual 2-, 3- and estimated 5-year survival rates were 17 months, 33%, 25%, and 18%, respectively.
  • Grade 3/4 toxicities consisted of neutropenia (92%), neutropenic fever (45%), nausea/vomiting (27%), diarrhea (35%), and hepatic toxicity (2%); there were no cases of treatment-related death.
  • CONCLUSION: This triplet chemotherapy has shown a promising activity against advanced NSCLC according to admission-based treatment with adequate supportive care.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy

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  • (PMID = 17410009.001).
  • [ISSN] 1556-1380
  • [Journal-full-title] Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
  • [ISO-abbreviation] J Thorac Oncol
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Taxoids; 15H5577CQD / docetaxel; 7673326042 / irinotecan; Q20Q21Q62J / Cisplatin; XT3Z54Z28A / Camptothecin
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21. Loizzi V, Rossi C, Cormio G, Cazzolla A, Altomare D, Selvaggi L: Clinical features of hepatic metastasis in patients with ovarian cancer. Int J Gynecol Cancer; 2005 Jan-Feb;15(1):26-31
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  • [Title] Clinical features of hepatic metastasis in patients with ovarian cancer.
  • The purpose of this study was to investigate the clinical features of hepatic metastasis in patients with epithelial ovarian cancer.
  • From 1998 to 2002, all women with hepatic metastasis from ovarian cancer were identified at the University of Bari.
  • Twenty-nine patients identified included one having stage IIC, one stage IIIA, two stage IIIB, 17 stage IIIC, and eight stage IVB.
  • Eight women had hepatic metastasis at the time of the diagnosis of ovarian cancer (group I), 10 patients had hepatic metastasis as first recurrence (group II), and 11 (group III) as a second relapse.
  • The median survival from the time of liver metastasis diagnosis was 19 months in group I patients, 24 months in group II patients, and 10 months in group III patients.
  • Cell type, performance status at the time of the primary tumor diagnosis, number of hepatic lesions, the presence of other sites of disease at the time of hepatic metastasis, and platinum-based chemotherapy were significantly related to survival.
  • Better performance status, serous cell-type tumor, single hepatic lesion, the absence of other sites of disease, and platinum-based chemotherapy are good prognostic factors.
  • [MeSH-minor] Aged. Antineoplastic Agents / therapeutic use. Female. Humans. Middle Aged. Neoplasm Staging. Risk Factors. Survival Analysis

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  • (PMID = 15670293.001).
  • [ISSN] 1048-891X
  • [Journal-full-title] International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
  • [ISO-abbreviation] Int. J. Gynecol. Cancer
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents
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22. Lin CM, Chen CH, Chang JW, Tsao TC: Phase II study of epirubicin in combination with weekly docetaxel for patients with advanced NSCLC who have failed or relapsed after the frontline platinum-based chemotherapy. Am J Clin Oncol; 2009 Apr;32(2):169-73
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  • [Title] Phase II study of epirubicin in combination with weekly docetaxel for patients with advanced NSCLC who have failed or relapsed after the frontline platinum-based chemotherapy.
  • BACKGROUND: We conducted a phase II study to evaluate the efficacy and toxicity of weekly docetaxel combined with epirubicin on D15 as second-line chemotherapy in Taiwanese patients with advanced non small cell lung cancer (NSCLC) who failed or relapsed after the frontline platinum-based chemotherapy.
  • PATIENTS AND METHODS: Patients with histologically confirmed advanced NSCLC (Stage IIIB-IV) were entered into this Phase II trial.
  • Treatment was repeated every 4 weeks for a maximal total of 6 cycles.
  • The median time to disease progression for all patients was 2.8 months (95% CI 1.3-4.3%).
  • The median survival time for all patients was 7.7 months (95% CI 5.5-9.9%).
  • Hepatic and renal impairment was also only mild.
  • CONCLUSION: Combining weekly doses of docetaxel 30 mg/m with epirubicin 60 mg/m on D15 was not shown to improve both efficacy and tolerability for advanced NSCLC patients who have relapsed disease after frontline platinum-based chemotherapy.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Carcinoma, Squamous Cell / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Epirubicin / administration & dosage. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / diagnosis. Neoplasm Staging. Prognosis. Salvage Therapy. Survival Rate. Taxoids / administration & dosage. Treatment Failure

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  • (PMID = 19307958.001).
  • [ISSN] 1537-453X
  • [Journal-full-title] American journal of clinical oncology
  • [ISO-abbreviation] Am. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Taxoids; 15H5577CQD / docetaxel; 3Z8479ZZ5X / Epirubicin
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23. Nogami N, Harita S, Ueoka H, Yonei T, Kiura K, Kamei H, Tabata M, Segawa Y, Gemba K, Tanimoto M: Phase I study of docetaxel and irinotecan in patients with advanced non-small-cell lung cancer. Lung Cancer; 2004 Jul;45(1):85-91
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  • [Title] Phase I study of docetaxel and irinotecan in patients with advanced non-small-cell lung cancer.
  • The role of non-platinum combination chemotherapy in the treatment of advanced non-small-cell lung cancer (NSCLC) has not yet been clarified.
  • In this phase I study, the dose-limiting toxicity (DLT), the maximum tolerable dose (MTD) and the antitumor activity of a two-drug combination of docetaxel (DCT) and irinotecan (CPT) in patients with advanced NSCLC were evaluated.
  • Previously untreated patients with NSCLC in stage IIIB with malignant pleural effusion or stage IV were eligible.
  • Both drugs were administered by 1-h intravenous infusion on day 1, and repeated every 3 weeks.
  • Since all the three patients treated at the fifth dose level (DCT at 60 mg/m2 and CPT at 165 mg/m2) experienced DLT (grade 4 neutropenia in two patients and grade 3 hepatic toxicity in one), this dose level was determined to be the MTD.
  • The objective response rate was 33.3%, and the median survival time was 13.6 months.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Camptothecin / analogs & derivatives. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy

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  • [Copyright] Copyright 2004 Elsevier Ireland Ltd.
  • (PMID = 15196738.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Journal Article
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Taxoids; 15H5577CQD / docetaxel; 7673326042 / irinotecan; XT3Z54Z28A / Camptothecin
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24. Shirai T, Hirose T, Noda M, Ando K, Ishida H, Hosaka T, Ozawa T, Okuda K, Ohnishi T, Ohmori T, Horichi N, Adachi M: Phase II study of the combination of gemcitabine and nedaplatin for advanced non-small-cell lung cancer. Lung Cancer; 2006 May;52(2):181-7
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  • [Title] Phase II study of the combination of gemcitabine and nedaplatin for advanced non-small-cell lung cancer.
  • We examined the efficacy and safety of the combination of gemcitabine and nedaplatin in patients with untreated advanced non-small-cell lung cancer.
  • Four patients had stage IIIB disease and 30 patients had stage IV disease.
  • One patient could not be evaluated for response because only one course of chemotherapy had been administered due to grade 3 eruption.
  • The median survival time was 9.0 months (range, 1-17 months).
  • Grades 3-4 nonhematological toxicities included nausea and vomiting in 6% of patients, diarrhea in 3%, and hepatic dysfunction in 9%.
  • There were no treatment-related deaths.
  • Our results suggest that the combination of gemcitabine and nedaplatin is an acceptable treatment for patients with previously untreated advanced non-small-cell lung cancer.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / analogs & derivatives. Immunosuppressive Agents / therapeutic use. Lung Neoplasms / drug therapy. Organoplatinum Compounds / therapeutic use
  • [MeSH-minor] Adult. Aged. Dose-Response Relationship, Drug. Drug Therapy, Combination. Female. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Staging. Retrospective Studies. Ribonucleotide Reductases / antagonists & inhibitors. Survival Rate. Treatment Outcome

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  • (PMID = 16563558.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Immunosuppressive Agents; 0 / Organoplatinum Compounds; 0W860991D6 / Deoxycytidine; 8UQ3W6JXAN / nedaplatin; B76N6SBZ8R / gemcitabine; EC 1.17.4.- / Ribonucleotide Reductases
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25. Miller AA, Case D, Atkins JN, Giguere JK, Bearden JD: Phase II study of carboplatin, irinotecan, and thalidomide in patients with advanced non-small cell lung cancer. J Thorac Oncol; 2006 Oct;1(8):832-6
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  • [Title] Phase II study of carboplatin, irinotecan, and thalidomide in patients with advanced non-small cell lung cancer.
  • BACKGROUND: We hypothesized that thalidomide would improve the response and toxicity profile of chemotherapy with carboplatin and irinotecan.
  • METHODS: The key eligibility criteria were stage IIIB (malignant pleural effusion) and IV non-small cell lung cancer, measurable disease, no prior chemotherapy, prior radiation only for brain metastasis, performance status 0 or 1, and adequate hematologic, hepatic, and renal function.
  • Treatment consisted of carboplatin at a calculated area under the curve of 5 and infused intravenously for 30 min on day 1 and irinotecan (50 mg/m2 intravenously for 90 min on days 1 and 8 every 21 days).
  • The objectives were to determine the response rate, time to progression, overall survival, and toxicity profile.
  • RESULTS: In all, 46 patients were enrolled, but three who never received protocol treatment were excluded from the analysis.
  • The characteristics of the 43 eligible and treated patients included median age 63 (47-79), female/male 13/30, black/white 3/40, PS 0/1 in 10/33, and stage 3/4 in 6/37.
  • The median time to progression was 3.7 months (95% confidence interval [CI], 2.5-4.9).
  • The median survival time was 8.1 months (95% CI, 5.0-12.9).
  • CONCLUSIONS: This treatment regimen of carboplatin, irinotecan, and thalidomide was tolerable, with reversible neutropenia as the major toxicity and only minor diarrhea.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy

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  • (PMID = 17409967.001).
  • [ISSN] 1556-1380
  • [Journal-full-title] Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
  • [ISO-abbreviation] J Thorac Oncol
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U10CA81851
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 4Z8R6ORS6L / Thalidomide; 7673326042 / irinotecan; BG3F62OND5 / Carboplatin; XT3Z54Z28A / Camptothecin
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26. Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F, MILES Investigators: The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer; 2008 Jul;61(1):67-72
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  • [Title] The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients.
  • BACKGROUND: Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC).
  • Aim of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion in the treatment of elderly patients with advanced NSCLC.
  • PATIENTS AND METHODS: Patients aged 70 years or older, with stage IV or IIIB (effusion/supraclavicular nodes) NSCLC, good performance status (0 or 1 according to ECOG classification) who had never received chemotherapy were eligible.
  • A single stage phase 2 design was applied, with 51 patients required to estimate a 25% +/- 10% response rate.
  • Ten responses were required to define the treatment as active.
  • The median time to disease progression was 16.1 weeks (95% C.I.: 11.1-20.6) and the median overall survival was 41.3 weeks (95% C.I.: 27.6-50.6).
  • Other non-haematological toxicities were: fatigue (44% of patients), grade 2-3 pulmonary toxicity (8%), grade 2-3 hepatic toxicity (16%).
  • CONCLUSION: Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design and should no longer be of interest for the treatment of elderly patients with advanced NSCLC.
  • [MeSH-major] Antimetabolites, Antineoplastic / administration & dosage. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / analogs & derivatives. Lung Neoplasms / drug therapy

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  • (PMID = 18683299.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
  • [Investigator] Gridelli C; Maione P; Rossi A; Barbera S; Renda F; Volpintesta A; Sannicolo M; Robbiati SF; Piazza E; Filipazzi V; Piantedosi F; Caputo F; Brancaccio L; Brunello V; Bearz A; Isa L; Capuano MA; Morena R; Rosetti F; Foa P; Passello G; Carrozza F; laffaioli RV; Galetta D; Barni S; Nettis G; Gallo C; Signoriello G; Chiodini P; Lama N; Perrone F; Morabito A; De Maio E; Di Maio M; Piccirillo MC
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27. Okuda K, Hirose T, Ishida H, Kusumoto S, Sugiyama T, Ando K, Shirai T, Ohnishi T, Horichi N, Ohmori T, Adachi M: Phase I study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol; 2008 Apr;61(5):829-35
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  • [Title] Phase I study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer.
  • PURPOSE: This trial was conducted to determine the maximum tolerated dose (MTD), principal toxicity, and recommended dose for phase II study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer (NSCLC).
  • METHODS: Patients with previously untreated NSCLC, either stage IIIB with pleural effusion or stage IV, were eligible if they had a performance status of 0-2, were 75 years or younger, and had adequate organ function.
  • Dose-limiting toxicities at the MTD were neutropenic fever and hepatic dysfunction.
  • Although the most frequent non-hematologic toxicity was hepatic dysfunction, all cases were only mildly to moderately severe.
  • Although two patients had grade 3 or 4 pulmonary toxicity due to Pneumocystis carinii pneumonia, these patients recovered after receiving trimetoprim-sulfamethoxazole, steroid therapy, and supplemental oxygen.
  • There were no treatment-related deaths.
  • CONCLUSION: This combination chemotherapy is active and well tolerated and warrants phase II study.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Aged. Dose-Response Relationship, Drug. Drug-Induced Liver Injury. Female. Fever / chemically induced. Humans. Male. Maximum Tolerated Dose. Middle Aged. Neutropenia / chemically induced. Organoplatinum Compounds / administration & dosage. Paclitaxel / administration & dosage. Severity of Illness Index. Treatment Outcome

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  • (PMID = 17589845.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 8UQ3W6JXAN / nedaplatin; P88XT4IS4D / Paclitaxel
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28. Gillenwater HH, Stinchcombe TE, Qaqish BF, Tyann M, Hensing TA, Socinski MA: A phase II trial of weekly paclitaxel and gemctiabine infused at a constant rate in patients with advanced non-small cell lung cancer. Lung Cancer; 2005 Mar;47(3):413-9
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  • [Title] A phase II trial of weekly paclitaxel and gemctiabine infused at a constant rate in patients with advanced non-small cell lung cancer.
  • BACKGROUND: Gemcitabine and paclitaxel both have significant single agent activity in non-small cell lung cancer (NSCLC).
  • Based on this, we designed a phase II trial to examine gemcitabine 800 mg/m2 infused over 80 min with paclitaxel 110 mg/m2 infused over 3 h both on days 1, 8 and 15 every 28 days as first line therapy in patients with advanced NSCLC.
  • Secondary objectives were to determine the effect of paclitaxel on the pharmacokinetic (PK) distribution of gemcitabine, the ability to achieve a concentration of 10-20 microM when gemcitabine was infused at a rate of 10 mg/(m2 min), as well as to assess the quality of life (QOL) with the functional assessment of cancer therapy-lung (FACT-L) questionnaire.
  • METHODS: Patients with NSCLC, no prior treatment, ECOG performance status (PS) 0-1, adequate bone marrow, renal, and hepatic function were eligible for this trial.
  • Nine PS = 0; 28 PS = 1; Stage IIIB = 3, Stage IV = 36; median age 62 (range: 39-77).
  • QOL as measured by the FACT-L and the trial outcome index (TOI) did not change significantly from baseline over the course of therapy.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / analogs & derivatives. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Paclitaxel / administration & dosage. Quality of Life. Survival Analysis. Treatment Outcome

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  • (PMID = 15713525.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; P88XT4IS4D / Paclitaxel
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29. Galetta D, Gebbia V, Giotta F, Durini E, Romito S, Borsellino N, Cazzato C, Pezzella G, Colucci G: Gemcitabine and docetaxel every 2 weeks in advanced non-small cell lung cancer: a phase II study of the Gruppo Oncologico Italia Meridionale. Lung Cancer; 2002 Oct;38(1):79-84
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  • [Title] Gemcitabine and docetaxel every 2 weeks in advanced non-small cell lung cancer: a phase II study of the Gruppo Oncologico Italia Meridionale.
  • INTRODUCTION: Platinum-based chemotherapy is the gold standard in advanced non-small cell lung cancer (NSCLC), although with relevant toxic effects.
  • Main inclusion criteria included untreated patients with histologically confirmed NSCLC, age</=70 years, stage IIIB/IV, Eastern Cooperative Oncology Group performance status (PS) 0-2, measurable disease, adequate hematologic, cardiac, hepatic and renal functions, and written informed consent.
  • Treatment schedule consisted of DCT at the dosage of 50 mg/m(2) with conventional steroid premedication and GEM at the dosage of 2,000 mg/m(2).
  • Both drugs were administered every 2 weeks without prophylactic use of growth factors.
  • There were 26 squamous carcinomas, 13 adenocarcinomas, and eight others, 13 stage IIIB and 34 stage IV.
  • Two treatment-not related deaths occurred before the first disease evaluation was performed.
  • In a statistical analysis responses were independent to histology or stage.
  • CONCLUSIONS: In our experience the biweekly combination of DCT and GEM is active and well tolerated and can be administered without G-CSF primary prophylaxis reducing treatment costs.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / analogs & derivatives. Lung Neoplasms / drug therapy. Paclitaxel / analogs & derivatives. Taxoids
  • [MeSH-minor] Aged. Cost Control. Disease Progression. Drug Costs. Female. Humans. Male. Middle Aged. Neutropenia / chemically induced. Survival. Treatment Outcome

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  • (PMID = 12367797.001).
  • [ISSN] 0169-5002
  • [Journal-full-title] Lung cancer (Amsterdam, Netherlands)
  • [ISO-abbreviation] Lung Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Taxoids; 0W860991D6 / Deoxycytidine; 15H5577CQD / docetaxel; B76N6SBZ8R / gemcitabine; P88XT4IS4D / Paclitaxel
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30. Winegarden JD, Mauer AM, Otterson GA, Rudin CM, Villalona-Calero MA, Lanzotti VJ, Szeto L, Kasza K, Hoffman PC, Vokes EE, University of Chicago Phase II Network, Ohio State University: A phase II study of oxaliplatin and paclitaxel in patients with advanced non-small-cell lung cancer. Ann Oncol; 2004 Jun;15(6):915-20
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  • [Title] A phase II study of oxaliplatin and paclitaxel in patients with advanced non-small-cell lung cancer.
  • PURPOSE: To evaluate the efficacy and toxicity of oxaliplatin and paclitaxel as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC).
  • PATIENTS AND METHODS: The treatment regimen was given as defined in a phase I investigation in patients with previously treated ovarian cancer.
  • Eligible patients had stage IIIB (pleural effusion)/IV NSCLC, measurable disease, no prior chemotherapy, Eastern Cooperative Oncology Group performance status 0-2, and adequate hematological, renal and hepatic function.
  • RESULTS: A total of 38 patients were enrolled with the following characteristics: 29% male (n = 11); 71% female (n = 27); median age 64.5 years (range 37-78); performance status of 0-1 84% (n = 32); stage IIIB 8% (n = 3); stage IV 92% (n = 35).
  • Median overall survival time was 9.2 months (95% CI 6-12.4) and median progression-free survival time was 4.3 months (95% CI 2.1-6.5).

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  • (PMID = 15151948.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / 5P30CA016058; United States / NCI NIH HHS / CM / CM107102-02; United States / NCI NIH HHS / CA / U01CA63187-01
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; P88XT4IS4D / Paclitaxel
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31. Krzakowski M, Provencio M, Utracka-Hutka B, Villa E, Codes M, Kuten A, Henke M, Lopez M, Bell D, Biti G, Merimsky O, Beorchia A, Riggi M, Caux NR, Pouget JC, Dubray B, David P: Oral vinorelbine and cisplatin as induction chemotherapy and concomitant chemo-radiotherapy in stage III non-small cell lung cancer: final results of an international phase II trial. J Thorac Oncol; 2008 Sep;3(9):994-1002
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  • [Title] Oral vinorelbine and cisplatin as induction chemotherapy and concomitant chemo-radiotherapy in stage III non-small cell lung cancer: final results of an international phase II trial.
  • INTRODUCTION: Cisplatin in combination with vinorelbine has reported an optimal activity/tolerance ratio when used in combination with radiotherapy in locally advanced unresectable non-small cell lung cancer.
  • MATERIAL AND METHODS: The study included patients between 18 and 75 years, with histologically proven untreated locally advanced inoperable stage IIIA/IIIB (supraclavicular lymph nodes and pleural effusion excluded) non-small cell lung cancer, adequate bone marrow, hepatic and renal function, Karnofsky performance status >/=80%.
  • Patients without progression received oral vinorelbine 40 mg/m day 1, 8 and cisplatin 80 mg/m day 1 every 3 weeks for 2 more cycles with radiotherapy 66 Gy in 6.5 weeks.
  • RESULTS: Patient and disease characteristics (n = 54) included: median age 57 years; female sex 24%; stage IIIA 48% and IIIB 52%; Squamous carcinoma 59%, Karnofsky performance status 100% (range, 80-100%) 50%, patients >/=5% weight loss at baseline 7%.
  • After two cycles of chemotherapy induction, the OR intent-to-treat in the 54 patients was 37%.
  • Forty-seven out of 54 (87%) patients received concomitant chemo-radiotherapy.Median radiotherapy delivered dose was 66 Gy.
  • CONCLUSION: Oral vinorelbine in combination with cisplatin is an effective combination in stage IIIA/IIIB patients.
  • Oral vinorelbine in combination with cisplatin is a new and promising option that facilitates the administration of concomitant chemo-radiotherapy with high rates of treatment completion.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Non-Small-Cell Lung / drug therapy. Carcinoma, Non-Small-Cell Lung / radiotherapy. Lung Neoplasms / drug therapy. Lung Neoplasms / radiotherapy
  • [MeSH-minor] Administration, Oral. Adult. Aged. Cisplatin / administration & dosage. Combined Modality Therapy. Female. Humans. International Agencies. Male. Middle Aged. Neoplasm Staging. Prognosis. Remission Induction. Survival Rate. Vinblastine / administration & dosage. Vinblastine / analogs & derivatives

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  • (PMID = 18758302.001).
  • [ISSN] 1556-1380
  • [Journal-full-title] Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
  • [ISO-abbreviation] J Thorac Oncol
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 5V9KLZ54CY / Vinblastine; Q20Q21Q62J / Cisplatin; Q6C979R91Y / vinorelbine
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32. Tavil Y, Arslan U, Okyay K, Sen N, Boyaci B: Atrial fibrillation induced by gemcitabine treatment in a 65-year-old man. Onkologie; 2007 May;30(5):253-5
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  • [Title] Atrial fibrillation induced by gemcitabine treatment in a 65-year-old man.
  • Major side effects of the treatment with gemcitabine are hepatic dysfunction, myelosuppression, renal impairment and pulmonary toxicity.
  • Development of atrial fibrillation (AF) during gemcitabine treatment is very rare and was reported in only 2 case reports in the literature.
  • CASE REPORT: We report the case of a 65-year-old man who developed AF under gemcitabine therapy for non-small cell lung cancer (stage IIIB).
  • In this patient, AF was intrinsically associated with chemotherapy administration which triggered arrhythmia.
  • [MeSH-major] Antimetabolites, Antineoplastic / adverse effects. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Atrial Fibrillation / chemically induced. Carcinoma, Non-Small-Cell Lung / drug therapy. Deoxycytidine / analogs & derivatives. Lung Neoplasms / drug therapy
  • [MeSH-minor] Aged. Cisplatin / administration & dosage. Cisplatin / adverse effects. Electrocardiography / drug effects. Humans. Infusions, Intravenous. Male. Neoplasm Staging. Risk Factors

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  • (PMID = 17460420.001).
  • [ISSN] 0378-584X
  • [Journal-full-title] Onkologie
  • [ISO-abbreviation] Onkologie
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; Q20Q21Q62J / Cisplatin
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