Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Colección de datos
Carcinoma+15
+ Enfermedades Urogenitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer. * Determine the toxicity of this regimen in these patients. Secondary * Determine the tolerance profile of patients treated with this regimen. * Determine a recommended phase III dose of this regimen in these patients. * Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients. * Determine the complete pathological response in patients treated with this regimen as first-line therapy. * Determine the duration of the objective response in patients treated with this regimen. * Determine the time to progression in patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A total of 30-39 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.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.De 18 a 75 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 cancer * Stage III or IV disease * Metastatic peritoneal, lymphatic, or visceral disease * Measurable or evaluable disease * Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-2 (0 in patients 70 to 75 years of age) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN * Alkaline phosphatase less than 2.5 times ULN Renal * Creatinine no greater than 1.4 mg/dL Other * No serious uncontrolled infection * No intolerance to polysorbate 80 * No peripheral neuropathy greater than grade 1 * No neurological or mental disease that would preclude study participation * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen * No prior oxaliplatin or docetaxel Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 28 days since prior participation in another clinical study * No other concurrent anticancer treatment
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 5 ubicaciones
Hopital Saint Antoine
Paris, FranceHopital Tenon
Paris, FrancePolyclinique De Courlancy
Reims, France