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Irinotecan in Treating Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003843
Recruitment Status : Terminated (Study terminated due to poor accrual)
First Posted : January 27, 2003
Last Update Posted : February 16, 2015
National Cancer Institute (NCI)
Information provided by:
California Cancer Consortium

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.

Condition or disease Intervention/treatment
Colorectal Cancer Drug: irinotecan hydrochloride Genetic: mutation analysis Genetic: polymorphism analysis

Detailed Description:


  • 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.

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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
Actual Primary Completion Date : February 2001
Actual Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 12 weeks


  • Granulocyte count greater than 1500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL


  • 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)


  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 12.0 mg/dL


  • No myocardial infarction within past 6 months
  • No congestive heart failure requiring therapy


  • No severe psychiatric disorders
  • No history of seizures


  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Prior oxaliplatin allowed
  • No prior irinotecan or topotecan

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003843

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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
Sponsors and Collaborators
California Cancer Consortium
National Cancer Institute (NCI)
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Study Chair: Heinz-Josef Lenz, MD University of Southern California
Layout table for additonal information Identifier: NCT00003843    
Other Study ID Numbers: CDR0000067003
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: September 2013
Keywords provided by California Cancer Consortium:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents