UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)
Drug Data
+ genetic Data
+ genetic Data
Colonic Diseases+10
+ Digestive System Diseases
+ Digestive System Neoplasms
Summary
Study start date: October 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
City of Hope Comprehensive Cancer Center
Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google MapsUSC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesUniversity of California Davis Cancer Center
Sacramento, United States