Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
NCT ID: NCT00170677
Last Updated: 2014-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
194 participants
INTERVENTIONAL
2005-09-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Topotecan
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
B
Topotecan
Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
Interventions
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Topotecan
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
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
Eligibility Criteria
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Inclusion Criteria
* 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
* simultaneous or planned radiotherapy
* secondary malignancy
18 Years
FEMALE
No
Sponsors
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North Eastern German Society of Gynaecological Oncology
OTHER
Responsible Party
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Principal Investigators
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Werner Lichtenegger
Role: STUDY_CHAIR
Charite University, Berlin, Germany
Locations
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Charité Campus Virchow-Klinikum
Berlin, , Germany
Countries
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Other Identifiers
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4401000
Identifier Type: -
Identifier Source: org_study_id
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