Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00087048
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Recurrence-free survival Safety and toxic effects Time to response and tumor response Quality of life
Trial Locations
- Locations (2)
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States