Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer
dexamethasone
+ gemcitabine hydrochloride
+ paclitaxel
Enfermedades Urogenitales+15
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine. Determine the toxic effects of this regimen in these patients. Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients. OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel). Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed until death. PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 35 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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 recurrent ovarian epithelial cancer Platinum resistant disease defined as: Progression during the most recent platinum-based chemotherapy OR Relapse less than 6 months after platinum-based chemotherapy Measurable or evaluable disease Elevated CA-125 only allowed Positive cytology only not eligible PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 3 times ULN Renal: Creatinine no greater than 2 mg/dL Neurologic: No peripheral neuropathy greater than grade 2 Other: No other serious medical illness or psychiatric conditions. PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics No prior gemcitabine No prior paclitaxel administered weekly Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from acute toxic effects secondary to prior therapy
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 una ubicación
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesAbrir USC/Norris Comprehensive Cancer Center and Hospital en Google Maps