Paclitaxel With or Without Carboplatin in Treating Patients With Advanced 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating patients who have recurrent, stage IIIB, or stage IV non-small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness|
|Study Start Date:||October 1997|
|Study Completion Date:||January 2006|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
|Experimental: Paclitaxel||Drug: paclitaxel|
|Experimental: Paclitaxel + Carboplatin||Drug: carboplatin Drug: paclitaxel|
OBJECTIVES: I. Compare the overall survival of patients with non-small cell lung cancer treated with paclitaxel alone or in combination with carboplatin. II. Compare the quality of life of these patients treated with these chemotherapy regimens. III. Compare the response rates and the toxic effects of the two regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to stage of disease (stage IIIB vs stage IV vs recurrent or progressive after surgery and/or radiotherapy), performance status (0-1 vs 2), and age (under 70 vs 70 and over). Patients are randomized to one of two treatment arms. Arm I receives paclitaxel IV over 3 hours on day 1 of each course. Arm II receives paclitaxel as in Arm I, followed by carboplatin IV over 1 hour. Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or unacceptable toxicity. Quality of life assessments are conducted before treatment and at 2, 6, 9, and 12 months. Patients are followed every 3 months for 2 years, then every 6 months until disease progression or death.
PROJECTED ACCRUAL: This study will accrue 600 patients over 2 years.
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|Study Chair:||Rogerio C. Lilenbaum, MD||Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center|