Lung Cancer Clinical Trial
Official title:
Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer
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 which regimen of chemotherapy is more
effective for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of
chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung
cancer.
OBJECTIVES: I. Compare gemcitabine plus vinorelbine vs standard chemotherapy containing
cisplatin in terms of the effect on the quality of life of patients with stage IIIB or IV
non-small cell lung cancer. II. Compare the effect of these regimens on the overall survival
of these patients. III. Compare the toxic effects of these regimens in these patients. IV.
Compare the effect of these regimens on the rate of objective response in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are
randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and
either gemcitabine IV or vinorelbine IV on days 1 and 8. Arm II: Patients receive
gemcitabine IV and vinorelbine IV on days 1 and 8. Treatment repeats every 21 days for up to
6 courses. Quality of life is assessed prior to therapy and before each course of
chemotherapy to the fourth course.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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