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| Descriptive Information Fields | |||||||||
| Brief Title † | Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy | ||||||||
| Official Title † | A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin | ||||||||
| Brief Summary | RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects. PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to prior therapy (irinotecan, fluorouracil, and leucovorin calcium vs fluorouracil and leucovorin calcium) and prior toxic effects (grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia). Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms. PROJECTED ACCRUAL: Approximately 308 patients will be accrued for this study. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | |||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Colorectal Cancer Diarrhea Neutropenia |
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| Intervention † | Procedure: mutation analysis Procedure: polymorphic microsatellite marker analysis |
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| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | |||||||||
| Start Date † | April 2002 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Canada, Puerto Rico | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00048971 | ||||||||
| Organization ID | CDR0000257145 | ||||||||
| Secondary IDs †† | CALGB-60102, NCCTG-CALGB-60102 | ||||||||
| Study Sponsor † | Cancer and Leukemia Group B | ||||||||
| Collaborators †† | National Cancer Institute (NCI) North Central Cancer Treatment Group |
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| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | December 2003 | ||||||||
| First Received Date † | November 12, 2002 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
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