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Irinotecan in Treating Patients With Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
irinotecan hydrochloride
mutation analysis
polymorphism analysis
Sponsored by
California Cancer Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • University of California Davis Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 13, 2015
Sponsor
California Cancer Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003843
Brief Title
Irinotecan in Treating Patients With Colorectal Cancer
Official Title
UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)
Study Type
Observational

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to poor accrual
Study Start Date
October 1998 (undefined)
Primary Completion Date
February 2001 (Actual)
Study Completion Date
February 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
California Cancer Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Lenz, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Irinotecan in Treating Patients With Colorectal Cancer

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