Back to resultsWeekly Topotecan Therapy in Patients With Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Cancer of the Ovary
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.
Sites / Locations
- Weill Medcial College of Cornell University
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00194935
First Posted
September 13, 2005
Last Updated
September 12, 2006
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00194935
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, Cancer of the Ovary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Caputo, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medcial College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weekly Topotecan Therapy in Patients With Ovarian Cancer
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