Expired Study
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New York, New York 10021


Purpose:

The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00194935


Primary Contact:

Principal Investigator
Thomas Caputo, M.D.
Weill Medical College of Cornell University


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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