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
Enfermedades Urogenitales+15
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 1999
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 10 ubicaciones
New York Hospital Medical Center of Queens
Fresh Meadows, United StatesAbrir New York Hospital Medical Center of Queens en 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