Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00002671
- Lead Sponsor
- NYU Langone Health
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with recurrent or unresectable epithelial ovarian cancer that has been previously treated with platinum-based chemotherapy.
- Detailed Description
OBJECTIVES: I. Determine the objective response rate in patients with advanced, recurrent, or inoperable ovarian epithelial cancer treated with aminocamptothecin as second-line therapy. II. Determine the toxic effects of this regimen in these patients. III. Correlate the topoisomerase-I levels with response in patients with accessible tumors treated with this regimen.
OUTLINE: Patients are stratified according to disease (measurable vs nonmeasurable). (The measurable disease stratum closed to accrual effective 08/1998.) Patients receive aminocamptothecin IV continuously on days 1-3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 4 additional courses past CR. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within approximately 15 months. (The measurable disease stratum closed to accrual effective 08/1998.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States