Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector
amifostine trihydrate
+ paclitaxel
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de julio de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel following amifostine in patients with recurrent or refractory solid tumors. II. Assess tumor response rate and survival in these patients. OUTLINE: This is a dose escalation study of paclitaxel. Patients receive amifostine IV over 5 minutes or less on day 0, followed by paclitaxel IV over 1 hour once a week for 6 weeks followed by 2 weeks of rest. Patients with complete or partial response may receive additional courses of therapy. Cohorts of 3-5 patients each receive increasing doses of paclitaxel. The maximum tolerated dose is defined as the dose level prior to the cohort at which 1 of 3-5 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 20 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.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
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.Criterios
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors Evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 4 months Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin less than 1.5 g/dL Alkaline phosphatase less than 3 times upper limit of normal (ULN) AST less than 3 times ULN Renal: Calcium greater than 8 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: No active congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No grade 2 neuropathy No intolerability for hydration PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No more than 3 prior failed chemotherapy regimens Prior paclitaxel as a radiosensitizer allowed No prior weekly paclitaxel infusion failure Prior platinum or paclitaxel therapy allowed Endocrine therapy: Prior endocrine therapy allowed Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed Other: No concurrent dilantin therapy No antihypertensive/diuretics within 24 hours prior to chemotherapy
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
State University of New York - Upstate Medical University
Syracuse, United StatesAbrir State University of New York - Upstate Medical University en Google Maps