A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer
docetaxel
Carcinoma de pulmón no microcítico+7
+ Carcinoma broncogénico
+ Neoplasias bronquiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unresectable stage IIIB or IV non-small cell lung cancer. Secondary * Compare the overall survival of patients treated with these regimens. * Compare the response rate in patients treated with these regimens. * Compare the incidence of serious adverse events in patients treated with these regimens. * Determine the quality of life of patients treated with these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion. Patients are followed at 1 month and then every 2-3 months thereafter. PROJECTED ACCRUAL: A total of 210-230 patients (105-115 per treatment arm) 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 6 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.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 or cytologically confirmed non-small cell lung cancer * Unresectable stage IIIB or IV disease * No untreated brain or leptomeningeal metastases * Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment * No symptomatic (i.e., requiring thoracentesis) pleural effusion * No clinically significant (i.e., grade 3 or greater) pericardial effusion PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 (70 years of age and over) OR * ECOG 2 (under 70 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 * Hemoglobin at least 8.0 g/dL Hepatic * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR * Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No grade 2 or greater peripheral neuropathy * No prior hypersensitivity reaction to taxanes or products containing polysorbate 80 * No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less) * No concurrent radiotherapy Surgery * More than 3 weeks since prior major surgery Other * More than 30 days since prior anticancer investigational drugs * Concurrent supportive care investigational agents allowed
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalCentros 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