Colorectal Cancer Clinical Trial
Official title:
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:
- Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with
either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon
cancer after treatment with irinotecan, fluorouracil, and leucovorin calcium.
- Determine whether polymorphisms in the TS enhancer and/or MTHFR gene are associated
with grade 3-4 diarrhea in these patients after treatment with fluorouracil and
leucovorin calcium.
- Determine whether polymorphisms in UGT1A1, TS, MTHFR, CYP3A4, or CYP3A5 are associated
with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment
with irinotecan, fluorouracil, and leucovorin calcium.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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