Trial Information

A Randomized Study of MVP 3 Versus 6 Cycles in Advanced Non-Small Cell Lung Cancer

OBJECTIVES: I. Compare the duration of symptom control, time to disease progression,
survival, and quality of life in patients with stage IIIB or IV non-small cell lung cancer
treated with 3 versus 6 courses of mitomycin, vinblastine, and cisplatin.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by stage of
disease (stage IIIB vs IV). Patients are randomized to 1 of 2 treatment arms: Arm I:
Patients receive cisplatin IV over 4 hours, mitomycin IV, and vinblastine IV on day 1.
Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Mitomycin is not administered during course 3. Arm II: Patients
receive chemotherapy as in arm I. Treatment repeats every 3 weeks for 6 courses in the
absence of disease progression or unacceptable toxicity. Mitomycin is not administered
during courses 3 and 5. Quality of life is assessed after completion of 3 courses of
chemotherapy for patients in arm I and after completion of 4, 5, and 6 courses for those in
arm II. Patients may receive radiotherapy beginning after completion of chemotherapy.

PROJECTED ACCRUAL: A total of 310 patients will be accrued for this study.