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UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan) (NCT00003843)

National Cancer Institute (NCI)
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.
  • Drug: irinotecan hydrochloride
    • Genetic: mutation analysis
      • Genetic: polymorphism analysis
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        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.

        3 locations

        United States (3)
        • City of Hope Comprehensive Cancer Center
          Not specified
          Duarte, California, United States, 91010
        • USC/Norris Comprehensive Cancer Center and Hospital
          Not specified
          Los Angeles, California, United States, 90033-0804
        • University of California Davis Cancer Center
          Not specified
          Sacramento, California, United States, 95817
        Status:
        terminated
        Type:
        Observational
        Phase:
        Start:
        30 September, 1998
        Updated:
        12 February, 2015
        Participants:
        28
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