UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)
Datos de Medicamento
+ genetic Data
+ genetic Data
Enfermedades del colon+10
+ Enfermedades del Sistema Digestivo
+ Neoplasias del sistema digestivo
Resumen
Fecha de inicio: 1 de octubre de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the frequency of genetic polymorphisms of UGT1 in Hispanics with colorectal cancer. Determine if pharmacokinetics of irinotecan and its metabolites, SN38 and SN38G, are associated with the genotype of UGT1 and clinical toxicity. Determine whether the genetic polymorphisms of UGT1 are associated with clinical toxicity and pharmacokinetics/pharmacodynamics of irinotecan in patients with unresectable colorectal cancer treated with irinotecan. Determine the response, time to progression, and survival in patients with UGT1A1 polymorphisms treated with irinotecan. OUTLINE: Genomic DNA is isolated from blood samples from patients and analyzed for UGT1 polymorphisms. Patients are stratified according to UGT1 genotype (homozygous for wild type vs heterozygous for abnormal allele vs homozygous for abnormal allele). Patients receive irinotecan over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 28 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 28 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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 advanced or disseminated colorectal cancer Progressive disease on fluorouracil based chemotherapy OR Recurrence of disease within 12 months of adjuvant therapy with fluorouracil No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 3 times ULN (no greater than 5 times ULN if liver involved) Renal: Creatinine no greater than 2.0 mg/dL Calcium no greater than 12.0 mg/dL Cardiovascular: No myocardial infarction within past 6 months No congestive heart failure requiring therapy Neurologic: No severe psychiatric disorders No history of seizures Other: No active or uncontrolled infection HIV negative No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled diabetes mellitus (random blood sugar 200 mg/dL or greater) No other severe concurrent disease Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior oxaliplatin allowed No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
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 3 ubicaciones
City of Hope Comprehensive Cancer Center
Duarte, United StatesAbrir City of Hope Comprehensive Cancer Center en Google MapsUSC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesUniversity of California Davis Cancer Center
Sacramento, United States