Irinotecan in Treating Patients With Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
California Cancer Consortium
ClinicalTrials.gov Identifier:
NCT00003843
First received: November 1, 1999
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: irinotecan hydrochloride
Genetic: mutation analysis
Genetic: polymorphism analysis
Phase 2

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

Resource links provided by NLM:


Further study details as provided by California Cancer Consortium:

Estimated Enrollment: 28
Study Start Date: October 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003843

Locations
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
Investigators
Study Chair: Heinz-Josef Lenz, MD University of Southern California
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003843     History of Changes
Other Study ID Numbers: CDR0000067003, LAC-USC-3C981, NCI-G99-1513
Study First Received: November 1, 1999
Last Updated: September 10, 2013
Health Authority: United States: Federal Government

Keywords provided by California Cancer Consortium:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014