Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/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
Cesare Gridelli, MD
Istituto Nazionale per lo Studio e la Cura dei Tumori
United States: Federal Government