Trial Information

Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

OBJECTIVES: I. Determine the activity and toxicities of gemcitabine in elderly patients with
non-small cell lung cancer. II. Determine the activity and toxicity of the combination of
gemcitabine and vinorelbine in these patients. III. Compare the survival rate and quality of
life of these patients treated with combination chemotherapy versus single agent
chemotherapy. IV. Compare objective response and time to progression of these patients
treated with these chemotherapy regimens. V. Compare the toxicities of these three regimens
in these patients. VI. Compare the number of hospitalizations, palliative radiation
therapies, antibiotic therapies, corticosteroid therapies, analgesic therapies, and
hematopoietic growth factor therapies needed for these patients treated with these
chemotherapy regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage
of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to
one of three treatment arms. Patients receive either vinorelbine IV, gemcitabine IV, or both
on days 1 and 8 of each 21 day course. Patients who achieve an objective response or stable
disease after 3 courses receive 3 more courses (for a total of 6 courses). Quality of life
is assessed before treatment, after course 4 (or 3 weeks after course 3, if therapy is
stopped), and at 21 days after course 6 (or 12 weeks after course 3).

PROJECTED ACCRUAL: A total of 630 patients (210 patients per arm) will be accrued for this
study.