- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003843
Irinotecan in Treating Patients With Colorectal Cancer
UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- CDR0000067003
- LAC-USC-3C981
- NCI-G99-1513
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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