A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
docetaxel
Enfermedades Urogenitales+15
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer. OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 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 ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy Platinum resistance as defined by one of the following: Relapse within 6 months of platinum based chemotherapy Residual disease after completion of platinum based chemotherapy Disease progression while receiving platinum based chemotherapy Marker only relapse (CA-125 elevation) and measurable disease Bidimensionally measurable disease on exam or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Performance status: ECOG 0-2 Life expectancy: Greater than 2 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGPT or SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Acceptable cardiac exam No active cardiac ischemia Pulmonary: Acceptable pulmonary exam No active pulmonary infection or compromise Other: Not pregnant or nursing No severe peripheral neuropathy (grade 2 or greater) No other significant psychiatric or medical conditions that would interfere with compliance No other malignancies within the past 3 years, except: Limited basal or squamous cell skin cancer Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cytokine therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer Prior paclitaxel allowed No prior docetaxel At least 3 years since prior chemotherapy for other disease Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: Not specified
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
Beth Israel Deaconess Medical Center
Boston, United StatesAbrir Beth Israel Deaconess Medical Center en Google Maps