Weekly Topotecan Therapy in Patients With Ovarian Cancer

Phase 2

Terminated

• Conditions: Ovarian Cancer

• Registration Number: NCT00194935
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2006-08
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-12
• Last Update Posted: 2006-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Patients must have a histopathologic diagnosis of epithelial ovarian cancer.
• Patients must have completed front-line chemotherapy and be clinically NED (CA 125 <35, negative CT scan, negative physical exam).
• Patients may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative).
• Patients must not have had other myelosuppressive therapy within four weeks of initiating topotecan therapy.
• Topotecan treatment must begin within 10 weeks following last cycle of initial chemotherapy.
• Patients may have had only one prior chemotherapy regimen.

Exclusion Criteria

• Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer.
• Patients who are pregnant or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Weill Medcial College of Cornell University; 🇺🇸 New York, New York, United States