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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
---|---|
Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00614965 |
This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC
Condition | Intervention | Phase |
---|---|---|
Non Small Cell Lung Cancer |
Drug: Irinotecan Drug: Cisplatin Drug: Pemetrexed |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-Line Treatment of Patients With Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 276 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
IC
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Drug: Irinotecan
Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Drug: Cisplatin
Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
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2: Experimental
PC
|
Drug: Cisplatin
Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Drug: Pemetrexed
Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles
|
Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Eva Maragkoudaki | +302810392857 | dorachat@med.uoc.gr |
Greece | |
IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106442666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Giassas, MD | |
Air Forces Military Hospital, Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Kentepozidis, MD |
Principal Investigator: | Sofia Aggelaki, MD | University Hospital of Crete, Dep of Medical Oncology |
Responsible Party: | Hellenic Oncology Research Group ( S.Aggelaki ) |
Study ID Numbers: | CT/06.16 |
Study First Received: | February 1, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00614965 |
Health Authority: | Greece: National Organization of Medicines |
Cancer NSCLC second-line chemotherapy irinotecan pemetrexed |
Folic Acid Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Irinotecan Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |