The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Overall survival
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall survival
Secondary Outcomes
- Recurrence-free survival
- Safety and toxic effects
- Time to response and tumor response
- Quality of life