Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
- Registration Number
- NCT00170677
- Brief Summary
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 194
Inclusion Criteria
- patients with histologically-confirmed ovarian cancer
- relapse within 6 month after primary therapy
- primary therapy with platin and taxan
- ECOG 0-2
- >= 18 years
- leukocytes >= 3.000/ µl
- platelet >= 100.000/ µl
- neutrophil >= 1.500/ µl
- written informed consent
Exclusion Criteria
- earlier topotecan therapy
- simultaneous or planned radiotherapy
- secondary malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Topotecan - B Topotecan -
- Primary Outcome Measures
Name Time Method Rate of CR and PR in each arm every 12 weeks
- Secondary Outcome Measures
Name Time Method Toxicity of topotecan treatment after each cycle Progression-free survival of both arms every 12 weeks
Trial Locations
- Locations (1)
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany