Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer
OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I),
gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with
advanced non-small cell lung cancer. II. Determine the response rate, duration of response,
progression-free survival, toxicity, and quality of life of these patients randomized in
these three treatment arms.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to
performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic).
Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin
IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and
cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1
followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III).
Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity
and disease progression, patients may receive up to 6 courses of treatment. Quality of life
is assessed before, during, and at the end of treatment, then every 6 weeks until disease
progression, and then every 3 months until death. Patients are followed every 6 weeks until
disease progression, then every 3 months until death.
PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this
study over 36 months.
Allocation: Randomized, Primary Purpose: Treatment
Egbert F. Smit, MD
Free University Medical Center
United States: Federal Government