Colon Cancer Clinical Trial
Irinotecan in Treating Patients With Colorectal Cancer
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.
Full 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 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
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There are 3 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Sacramento California, 95817, United States
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