Topotecan in Treating Patients With Recurrent Extensive-Stage 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer|
- Overall survival [ Designated as safety issue: No ]
- Safety and toxic effects [ Designated as safety issue: Yes ]
- Recurrence-free survival [ Designated as safety issue: No ]
- Time to response and tumor response [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087048
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Afshin Dowlati, MD||Case Comprehensive Cancer Center|