Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Colección de datos
Carcinoma+9
+ Adenocarcinoma
+ Enfermedades del Sistema Digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2001
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy. Secondary * Determine the survival without local relapse and overall survival of patients treated with this regimen. * Determine the tolerance to this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 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.Cualquier sexo
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 adenocarcinoma of the stomach * Locally advanced or metastatic disease * Measurable disease * At least 1 unidimensionally measurable target lesion at least 2 cm in diameter * No known symptomatic brain metastases * No bone metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin less than 2 times normal * AST and ALT no greater than 2.5 times normal * Alkaline phosphatase no greater than 2.5 times normal Renal * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular * No serious cardiac failure within the past 12 months * No myocardial infarction within the past 12 months * No cardiac insufficiency * No angina Other * Not pregnant or nursing * Fertile patients must use effective contraception * No uncontrolled serious infection * No significant brain or psychiatric disorders * No intolerance to cortisone or polysorbate 80 * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No other illness or medical condition that would preclude study participation * No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 21 days since prior participation in another clinical study * No other concurrent experimental medication
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 23 ubicaciones
Centre Hospitalier Victor Dupouy
Argenteuil, FranceCentre Hospital General Robert Ballanger
Aulnay Sous Bois, FranceC.H.G. Beauvais
Beauvais, France