Spots Global Cancer Trial Database for Irinotecan in Treating Patients With Colorectal Cancer

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Trial Identification

Brief Title: Irinotecan in Treating Patients With Colorectal Cancer

Official Title: UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)

Study ID: NCT00003843

Conditions

Colorectal Cancer

Interventions

irinotecan hydrochloride

mutation analysis

polymorphism analysis

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer.

Detailed Description: 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.