A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
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.
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.
DISEASE CHARACTERISTICS:
Histologically confirmed stage III adenocarcinoma of the colon
Enrolled on CALGB-89803 and must fall into 1 of the following categories:
Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following:
Received fluorouracil and leucovorin calcium and experienced at least 1 of the following:
PATIENT CHARACTERISTICS:
Age
Los Angeles, California 90048, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20422, United States
Fort Wayne, Indiana 46885-5099, United States
Baltimore, Maryland 21201, United States
Boston, Massachusetts 02115, United States
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Columbia, Missouri 65203, United States
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Syracuse, New York 13217, United States
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