Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in 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. It is not yet known which regimen of rebeccamycin analogue is
more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue
regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell
lung cancer.
OBJECTIVES:
- Compare the efficacy, in terms of response rate, in patients with advanced or recurrent
non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily
infusions every 3 weeks.
- Compare the response duration in patients treated with these regimens.
- Compare the toxicity profiles of these two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of
two treatment arms.
- Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1.
- Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment
for both arms repeats every 3 weeks for 6-8 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study
at a rate of 3-4 patients per month.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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