Weekly Topotecan Therapy in Patients With Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT00194935
• Recruitment Status: Terminated
• First Posted: September 19, 2005
• Last Update Posted: September 13, 2006
• Sponsor: Weill Medical College of Cornell University
• Information provided by: Weill Medical College of Cornell University

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 19, 2005
• Last Update Posted Date: September 13, 2006
• Study Start Date: February 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 13, 2005): The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 13, 2005): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Weekly Topotecan Therapy in Patients With Ovarian Cancer
• Official Title: A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer
• Intervention: Drug: Topotecan
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: September 13, 2005): 32
• Original Enrollment: Same as current
• Study Completion Date: August 2006
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00194935
• Other Study ID Numbers: 0103-636
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Weill Medical College of Cornell University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Weill Medical College of Cornell University
• Verification Date: September 2006