Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
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 ID: NCT00005051
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Howard S. Hochster, MD
Affiliation: NYU Langone Health
Role: STUDY_CHAIR
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