Gemcitabine Plus Carboplatin or Cisplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent 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 II trial to compare the effectiveness of gemcitabine plus carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer|
|Study Completion Date:||August 2004|
OBJECTIVES: I. Determine the response rates of gemcitabine and carboplatin vs gemcitabine and cisplatin in patients with stage IIIB, IV, or recurrent non-small cell lung cancer. II. Determine the toxicity of these two regimens in this patient population. III. Determine the time to progression and one year survival of these patients on these regimens.
OUTLINE: This is a randomized study. Patients are stratified by stage of disease and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by carboplatin over 60 minutes on day 1. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by cisplatin IV over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months, every two months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 1 year.