Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00005051
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.
- Detailed Description
OBJECTIVES:
* Determine the toxicity and tolerance of sequential therapy with prolonged
* Determine the response rate and time to progression in this patient
* Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.
OUTLINE:
* Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
* Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
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 (10)
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
New York Hospital Medical Center of Queens
🇺🇸Fresh Meadows, New York, United States
Saint Vincent Catholic Medical Center of New York
🇺🇸New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
🇺🇸New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Albert Einstein Clinical Cancer Center🇺🇸Bronx, New York, United States