Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT00017459
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2000-07-31
2004-02-29
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive tirapazamine IV over 2 hours followed by cisplatin IV over 1 hour on day 1. Patients also receive vinorelbine IV over 6-10 minutes on days 1, 8, 15, and 22. Arm II: Patients receive cisplatin and vinorelbine as in arm I. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, during each course of treatment, at 30 days after the last course of treatment, and then every 8 weeks for 2-3 years. Patients are followed every 8 weeks for 2-3 years.
PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cisplatin
tirapazamine
vinorelbine tartrate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine normal Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell carcinoma that is not likely to recur No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) used on this study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for NSCLC Chemotherapy: No prior chemotherapy for NSCLC No prior platinum-based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to potential indicator lesion(s) At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgical procedure(s) Other: At least 30 days since prior investigational drug
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Elwyn Y. Loh, MD
Role: STUDY_CHAIR
Sanofi
Locations
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Tower Hematology Oncology Medical Group
Los Angeles, California, United States
Medical Oncology Internal Medicine
Los Angeles, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Medical Oncology Care Associates
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, United States
Medical Oncology-Hematology Consultants, P.A.
Wilmington, Delaware, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
Watson Clinic
Lakeland, Florida, United States
Ocala Research Institute, Inc
Ocala, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Dreyer Medical Clinic
Aurora, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Northwest Oncology and Hematology, S.C.
Elk Grove Village, Illinois, United States
Rockford Clinic
Rockford, Illinois, United States
Cancer Care Center
New Albany, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Hematology-Oncology Clinic
Baton Rouge, Louisiana, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Western Montana Clinic
Missoula, Montana, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
Akron General Medical Center
Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
North Penn Hospital
Lansdale, Pennsylvania, United States
Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, United States
Lone Star Oncology
Austin, Texas, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States
Southwest Cancer Center at University Medical Center
Lubbock, Texas, United States
Baptist Health System Cancer Program
San Antonio, Texas, United States
Cancer Therapy Research Center
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
Arlington-Fairfax Hematology/Oncology, PC
Arlington, Virginia, United States
Countries
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Other Identifiers
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CDR0000068690
Identifier Type: REGISTRY
Identifier Source: secondary_id
SANOFI-EFC3675
Identifier Type: -
Identifier Source: org_study_id