Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
Colección de datos
Carcinoma+11
+ Enfermedades Urogenitales
+ Adenocarcinoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 2006
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin. Secondary * Determine the tolerability of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 22 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.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 120 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 collecting duct renal cell carcinoma * Advanced locally recurrent or metastatic disease * Not amenable to resection * Measurable disease * No active CNS metastases * Patients with CNS metastases previously treated with surgical resection and/or radiotherapy are eligible provided there is no evidence of disease progression by head CT scan or MRI at 3 months after the completion of definitive therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 2 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy greater than grade 1 * No other prior malignancy except for curatively treated cancer from which the patient has been disease-free for the length of time considered appropriate for cure of the specific cancer * No known hypersensitivity to Cremophor EL * No active serious infection * No other serious underlying medical condition that would preclude study therapy * No dementia or significantly altered mental status that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 2 prior biologic response modifier (BRM) regimens * Regimens may have included interleukin-2 and/or interferon alfa * At least 4 weeks since prior BRM therapy Chemotherapy * Not specified Endocrine therapy * Concurrent corticosteroids allowed Radiotherapy * See Disease Characteristics * Prior radiotherapy allowed provided there is measurable disease that has not been irradiated OR there is clear evidence of tumor progression in an irradiated site * At least 4 weeks since prior radiotherapy * No concurrent external beam radiotherapy Surgery * See Disease Characteristics * No concurrent major surgery Other * No other concurrent anticancer drugs
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 35 ubicaciones
Baptist Cancer Institute - Jacksonville
Jacksonville, United StatesAbrir Baptist Cancer Institute - Jacksonville en Google MapsRush-Copley Cancer Care Center
Aurora, United StatesRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesHematology and Oncology Associates
Chicago, United States