PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES
paclitaxel
Enfermedades Estomatognáticas+5
+ Enfermedades de la boca
+ Neoplasias de la boca
Estudio de Tratamiento
Resumen
Fecha de inicio: 30 de mayo de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Estimate the response rate in patients with metastatic or recurrent salivary gland cancer treated with paclitaxel (Taxol, TAX) by 3-hour infusion. II. Describe the toxicity of TAX in these patients. OUTLINE: Single-Agent Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, TAX, NSC-125973. PROJECTED ACCRUAL: Up to 32 patients/histology will be entered. If no response is observed in the first 14 patients in a particular histology, accrual to that group will close; if after 18 months annual accrual is less than 10 patients/histology, accrual to that group may close.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 32 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 salivary gland carcinoma that is metastatic or recurrent, including the following types: Mucoepidermoid carcinoma Adenocarcinoma Pathology review required Measurable disease required Lesion in a previously irradiated field must be progressing and biopsy- proven PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,000/mm3 ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hb at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No MI within the past 6 months No CHF No unstable arrhythmia No current antiarrhythmic, inotropic, or antianginal medication Other: No history of allergy to Cremophor No prior malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer Curatively treated in-situ cancer of the cervix No concurrent malignancy Not pregnant or nursing Effective contraception strongly advised for fertile patients Blood/body fluid analyses to determine eligibility and imaging studies and scans/x-rays for tumor measurement completed within 14 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifier therapy allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed with recovery Surgery: Prior surgery allowed with recovery
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 29 ubicaciones
Veterans Affairs Medical Center - Palo Alto
Palo Alto, United StatesAbrir Veterans Affairs Medical Center - Palo Alto en Google MapsStanford University Medical Center
Stanford, United StatesH. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesEmory University Hospital - Atlanta
Atlanta, United States