Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
carboplatin
+ cisplatin
+ paclitaxel
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery Stage IC, II, III, or IV PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: SGOT no greater than 3 times upper limit of normal Bilirubin no greater than 2.0 mg/dL No clinically significant hepatic disorder Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min No clinically significant renal disorder Cardiovascular: No clinically significant cardiovascular condition Other: Normal GI function allowing reliable administration of oral medication No active infection requiring systemic medical therapy within past week No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder) No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No dementia or altered mental status that would preclude consent Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for ovarian epithelial carcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for ovarian epithelial carcinoma Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
New York Hospital Medical Center of Queens
Fresh Meadows, United StatesOpen New York Hospital Medical Center of Queens in Google MapsSaint Vincent Catholic Medical Center of New York
New York, United StatesNYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, United StatesSt. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, United States