Lung Cancer Clinical Trial
Official title:
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line
therapy in treating patients with recurrent extensive-stage small cell lung cancer.
OBJECTIVES:
Primary
- Determine the overall survival of patients with recurrent extensive stage small cell
lung cancer treated with high-dose topotecan hydrochloride.
Secondary
- Determine the safety and toxic effects of this drug in these patients.
- Determine the recurrence-free survival of patients treated with this drug.
- Determine time to response and tumor response in patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22,
29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end
of study treatment, and then every 3 months thereafter.
Patients are followed at 7-14 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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