A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
Thomas Caputo, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Medcial College of Cornell University||New York, New York 10021|