Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00017459
- Lead Sponsor
- Sanofi
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if cisplatin and vinorelbine are more effective with or without tirapazamine in treating non-small cell lung cancer
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
OBJECTIVES: I. Compare the overall survival duration of patients with stage IIIB or IV non-small cell lung cancer treated with vinorelbine and cisplatin with or without tirapazamine. II. Compare the complete and partial response rates, time to disease progression, and time to treatment failure in these patients treated with these regimens. III. Compare the clinical benefit of these regimens, in terms of performance status and body weight, in these patients. IV. Compare the toxicity and safety of these regimens in these patients. V. Compare the quality of life of patients treated with these regimens.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
University of Florida Health Science Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
Los Angeles County Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Bay Area Tumor Institute
🇺🇸Oakland, California, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Tower Hematology Oncology Medical Group
🇺🇸Los Angeles, California, United States
Medical Oncology Internal Medicine
🇺🇸Los Angeles, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Fox Chase - Temple Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Center for Oncology Research and Treatment, Medical City Hospital
🇺🇸Dallas, Texas, United States
Rockford Clinic
🇺🇸Rockford, Illinois, United States
Capitol Comprehensive Cancer Care Clinic
🇺🇸Jefferson City, Missouri, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Cancer Therapy Research Center
🇺🇸San Antonio, Texas, United States
Southwest Cancer Center at University Medical Center
🇺🇸Lubbock, Texas, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Dreyer Medical Clinic
🇺🇸Aurora, Illinois, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Ocala Research Institute, Inc
🇺🇸Ocala, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Lone Star Oncology
🇺🇸Austin, Texas, United States
Baptist Health System Cancer Program
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Arlington-Fairfax Hematology/Oncology, PC
🇺🇸Arlington, Virginia, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
North Penn Hospital
🇺🇸Lansdale, Pennsylvania, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Brookdale University Hospital and Medical Center
🇺🇸Brooklyn, New York, United States
Hematology-Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Western Montana Clinic
🇺🇸Missoula, Montana, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Medical Oncology-Hematology Consultants, P.A.
🇺🇸Wilmington, Delaware, United States
Northwest Oncology and Hematology, S.C.
🇺🇸Elk Grove Village, Illinois, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States