Status:
COMPLETED
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
- earlier topotecan therapy
- simultaneous or planned radiotherapy
- secondary malignancy
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00170677
Start Date
September 1 2005
End Date
January 1 2013
Last Update
May 14 2014
Active Locations (1)
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1
Charité Campus Virchow-Klinikum
Berlin, Germany, 13533