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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Heinz-Josef Lenz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067003

NCT ID:

NCT00003843

Start Date:

October 1998

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010