Lung Cancer Clinical Trial
Official title:
Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV 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 two regimens of docetaxel
plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung
cancer.
OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell
lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the
toxicity of this treatment in these patients. III. Describe the quality of life parameters
of patients receiving this combination therapy. IV. Determine the survival rate of these
patients.
OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage
IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms
(Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by
gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II:
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and
15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15.
Patients continue treatment every 28 days for a maximum of 6 courses in the absence of
unacceptable toxicity or disease progression. Patients with either stable disease or
complete/partial response who discontinue treatment after 4-6 courses may be eligible for
NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of
therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18
months.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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