Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
18 Years
N/A
Female
Ovarian Cancer
Trial Information
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of CR and PR in each arm
Outcome Time Frame:
every 12 weeks
Safety Issue:
No
Principal Investigator
Werner Lichtenegger
Investigator Role:
Study Chair
Investigator Affiliation:
Charité Campus Virchow Klinikum
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
4401000
NCT ID:
NCT00170677
Start Date:
September 2005
Completion Date:
February 2011
Related Keywords:
- Ovarian Cancer
- Ovarian Neoplasms
Name | Location |
|---|
