A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL
chemotherapy
+ cisplatin
+ paclitaxel
Carcinoma+11
+ Carcinoma de Células Escamosas
+ Enfermedades del Sistema Digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Estimate the maximum tolerated dose and recommend a phase II dose for paclitaxel (TAX) when administered as a 96-hour intravenous infusion with a weekly fixed dose of intravenous cisplatin (CDDP) during concurrent radiotherapy for patients with localized esophageal cancer. II. Estimate the response rate of patients treated with 2 courses of TAX/CDDP induction chemotherapy and the complete response rate of patients treated with TAX/CDDP and concurrent radiotherapy. III. Describe the toxic effects of TAX/CDDP prior to and during radiotherapy. IV. Describe the pharmacokinetics of TAX as a continuous infusion (CI) over 96 hours. V. Evaluate, by flow cytometry, the ability of CI TAX to block esophageal cancer cells in the G2-M phase of the cell cycle. OUTLINE: After the MTD of TAX is reached on Part A, new patients are entered on Part B. The following acronyms are used: CDDP Cisplatin, NSC-119875 EBRT External-beam radiotherapy TAX Paclitaxel (Bristol-Myers), NSC-125973 PART A: Radiotherapy plus 2-Drug Combination Chemotherapy. EBRT using megavoltage equipment (>/= 10 MV recommended; electron boost allowed for subclavicular fossae); plus TAX/CDDP. PART B: 2-Drug Combination Induction Chemotherapy followed by Radiotherapy plus 2-Drug Combination Chemotherapy. TAX/CDDP; followed by EBRT as in Part A; plus TAX/CDDP. PROJECTED ACCRUAL: At least 3 patients/dose will be entered on Part A (up to 24 patients) and 3-6 patients on Part B.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 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 confirmed epidermoid carcinoma or adenocarcinoma of the esophagus eligible for potentially curative radiotherapy Disease in one of the following categories: Newly diagnosed Locoregional failure after prior resection with curative intent Positive microscopic margin after palliative resection of all gross disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial invasion on bronchoscopy, including tracheoesophageal fistula PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA class 3/4 status No cerebral vascular disease No hypertension Other: No severe uncontrolled diabetes No uncontrolled infection No other medical condition that precludes treatment No mental status abnormality that precludes comprehension of or compliance with treatment No active cancer arising at another primary site other than basal cell carcinoma of the skin or in situ cervical carcinoma PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google Maps