Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
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.
Drug: topotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)|
|Study Start Date:||August 1999|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005051
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|New York Hospital Medical Center of Queens|
|Fresh Meadows, New York, United States, 11365|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Saint Vincent Catholic Medical Center of New York|
|New York, New York, United States, 10011|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division|
|New York, New York, United States, 10019|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-3236|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|