Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
Recruitment status was Active, not recruiting
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer|
- Rate of CR and PR in each arm [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
- Toxicity of topotecan treatment [ Time Frame: after each cycle ] [ Designated as safety issue: Yes ]
- Progression-free survival of both arms [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||February 2011|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.
|Charité Campus Virchow-Klinikum|
|Berlin, Germany, 13533|
|Study Chair:||Werner Lichtenegger||Charité Campus Virchow Klinikum|