A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
irinotecan hydrochloride
Adenocarcinoma+14
+ Carcinoma
+ Infecciones por virus ADN
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors. Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population. OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 10-31 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.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 proven metastatic or unresectable high grade neuroendocrine tumor including: Small cell carcinoma Large cell neuroendocrine carcinoma Other high grade neuroendocrine carcinomas without specification to cell size No lung only involvement without any other primary site No primary small cell lung cancer with or without metastases Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm High grade tumor indicated by at least one of the following: Growth pattern suggestive of neuroendocrine differentiation Mitotic rate greater than 15 mitoses per 10 hpf Presence of abundant necrosis Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Granulocyte count at least 1,500/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No uncontrolled congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric or other disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 2 prior chemotherapy regimens No prior camptothecins Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
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