Irinotecan in Treating Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003843|
Recruitment Status : Terminated (Study terminated due to poor accrual)
First Posted : January 27, 2003
Last Update Posted : February 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: irinotecan hydrochloride Genetic: mutation analysis Genetic: polymorphism analysis||Phase 2|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||28 participants|
|Official Title:||UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)|
|Study Start Date :||October 1998|
|Primary Completion Date :||February 2001|
|Study Completion Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003843
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Study Chair:||Heinz-Josef Lenz, MD||University of Southern California|