Spots Global Cancer Trial Database for Weekly Topotecan Therapy in Patients With Ovarian Cancer
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Trial Identification
Brief Title: Weekly Topotecan Therapy in Patients With Ovarian Cancer
Official Title: A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
Study ID: NCT00194935
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.
Detailed Description: Patients with Stage IIIC and IV optimally-debulked ovarian cancer will be treated with 6 cycles (every 3 weeks) of carboplatin (AUC 5) and paclitaxel (175 mg/m2). Patients who demonstrate a complete clinical response to this regimen will then be treated with topotecan consolidation (4 mg/m2 weekly x 8 weeks for one cycle followed by a break in the 9th week) for a maximum of 3 cycles. Primary endpoints will be toxicity and the determination of the appropriate dose, schedule, and duration of topotecan for further consolidation trials.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Weill Medcial College of Cornell University, New York, New York, United States
Contact Details
Name: Thomas Caputo, M.D.
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR
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