Weekly Topotecan Therapy in Patients With Ovarian Cancer
The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy|
- The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
- To determine the efficacy (Progression free survival) of weekly topotecan as consolidation therapy in ovarian cancer patients who are clinically NED or have microscopic disease only after first-line chemotherapy.
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||August 2006|
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.
|United States, New York|
|Weill Medcial College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Thomas Caputo, M.D.||Weill Medical College of Cornell University|