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Sponsored by: |
North Eastern Germany Society of Gynaecologic Oncology |
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Information provided by: | North Eastern Germany Society of Gynaecologic Oncology |
ClinicalTrials.gov Identifier: | NCT00170677 |
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: Topotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Enrollment: | 194 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: Topotecan
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
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B: Experimental |
Drug: 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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charité Campus Virchow-Klinikum | |
Berlin, Germany, 13533 |
Study Chair: | Werner Lichtenegger | Charité Campus Virchow Klinikum |
Responsible Party: | Charité-Universitätsmedizin Berlin ( Jalid Sehouli, Prof. Dr. med. ) |
Study ID Numbers: | 4401000 |
Study First Received: | September 13, 2005 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00170677 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Topotecan Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Adnexal Diseases |