Irinotecan in Treating Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003843
• Other study ID #: CDR0000067003
• Secondary ID: LAC-USC-3C981NCI
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 13, 2015
• Start date: October 1998
• Est. completion date: February 2001

Study information

• Verified date: September 2013
• Source: California Cancer Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: February 2001
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

Genetic:
• mutation analysis

• polymorphism analysis

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	University of California Davis Cancer Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
California Cancer Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,