Lung Cancer Clinical Trial

Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB or IV Newly diagnosed or recurrent disease Measurable lesions At least 10 mm by spiral CT scan OR At least 20 mm by conventional techniques Previously irradiated lesions are considered measurable provided they progressed or appeared after completion of radiotherapy The following are considered nonmeasurable: Pleural or pericardial effusions Cystic lesions Lymphangitis pulmonis Bony x-ray abnormalities Abnormal scans with nonmeasurable filling defects No symptomatic brain metastasis or CNS involvement by CT scan or MRI

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT00017459

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 42 Locations for this study

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Tower Hematology Oncology Medical Group
Los Angeles California, 90048, United States
Medical Oncology Internal Medicine
Los Angeles California, 90067, United States
Bay Area Tumor Institute
Oakland California, 94609, United States
Medical Oncology Care Associates
Orange California, 92668, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94143, United States
John Wayne Cancer Institute
Santa Monica California, 90404, United States
Los Angeles County Harbor-UCLA Medical Center
Torrance California, 90509, United States
Medical Oncology-Hematology Consultants, P.A.
Wilmington Delaware, 19808, United States
Washington Cancer Institute
Washington District of Columbia, 20010, United States
Veterans Affairs Medical Center - Washington, DC
Washington District of Columbia, 20422, United States
University of Florida Health Science Center - Jacksonville
Jacksonville Florida, 32209, United States
Watson Clinic
Lakeland Florida, 33804, United States
Ocala Research Institute, Inc
Ocala Florida, 34471, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Saint Alphonsus Regional Medical Center
Boise Idaho, 83706, United States
Dreyer Medical Clinic
Aurora Illinois, 60506, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Northwest Oncology and Hematology, S.C.
Elk Grove Village Illinois, 60007, United States
Rockford Clinic
Rockford Illinois, 61103, United States
Cancer Care Center
New Albany Indiana, 47150, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Hematology-Oncology Clinic
Baton Rouge Louisiana, 70808, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City Missouri, 65109, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Missouri, 64128, United States
St. John's Mercy Medical Center
Saint Louis Missouri, 63141, United States
Western Montana Clinic
Missoula Montana, 59803, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
Brookdale University Hospital and Medical Center
Brooklyn New York, 11212, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
New York Medical College
Valhalla New York, 10595, United States
Akron General Medical Center
Akron Ohio, 44302, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
North Penn Hospital
Lansdale Pennsylvania, 19446, United States
Fox Chase - Temple Cancer Center
Philadelphia Pennsylvania, 19140, United States
Lone Star Oncology
Austin Texas, 78759, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas Texas, 75230, United States
Southwest Cancer Center at University Medical Center
Lubbock Texas, 79415, United States
Baptist Health System Cancer Program
San Antonio Texas, 78205, United States
Cancer Therapy Research Center
San Antonio Texas, 78229, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
Arlington-Fairfax Hematology/Oncology, PC
Arlington Virginia, 22205, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT00017459

Recruitment Status:

Completed

Sponsor:


Sanofi

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