A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer
irinotecan hydrochloride
+ surgical procedure
Enfermedades del colon+10
+ Enfermedades del Sistema Digestivo
+ Neoplasias del sistema digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Evaluate the clinical usefulness of preoperative irinotecan in patients with high risk, technically resectable metastatic colorectal cancer that is refractory to fluorouracil. II. Evaluate prospectively the relationship between expression of selected molecular determinants of response and clinical responsiveness to irinotecan in these patients. III. Determine the effect of treatment with irinotecan on the expression of putative response determinants in these patients. OUTLINE: This is an open label study. Patients receive irinotecan IV over 90 minutes weekly for 4 consecutive weeks. Course repeats every 6 weeks. After 2 courses, CT scan is obtained and patients showing evidence of disease that is still amenable to surgical resection undergo surgery. Approximately 4-8 weeks after surgical resection, patients receive 3 additional courses of irinotecan in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for years 3 and 4. PROJECTED ACCRUAL: A total of 30 patients will be accrued into 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.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 technically resectable metastatic colorectal cancer that is high risk for relapse Must meet one of the following criteria: Metastatic colorectal cancer confined to liver plus portal lymph nodes Recurrent metastatic colorectal cancer confined to liver after first hepatic resection Metastatic colorectal cancer confined to lung plus liver Metastatic colorectal cancer confined to liver with MSKCC risk factor score greater than 4 Metastatic colorectal cancer confined to lung, with either greater than 1 nodule and/or less than 3 years disease free survival Metastatic colorectal cancer confined to ovary Metastatic colorectal cancer confined to a single intraabdominal lymph node Must have failed fluorouracil-based chemotherapy for metastatic disease, received fluorouracil-based chemotherapy in adjuvant setting, have tumor with measured thymidylate synthase level greater than 4.0, or have lung metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction in the last 6 months Other: No other prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No active or uncontrolled infection No psychiatric or other disorders No other concurrent disease that would preclude entry into this study Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan or other camptothecins Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
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