Status:
TERMINATED
Weekly Topotecan Therapy in Patients With Ovarian Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer.
- Patients who are pregnant or breast-feeding.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00194935
Start Date
February 1 2003
End Date
August 1 2006
Last Update
September 13 2006
Active Locations (1)
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1
Weill Medcial College of Cornell University
New York, New York, United States, 10021