Overview
This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (1/28) (heterozygotes) and usual UGT metabolizers (1/1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (1/28, 1/1) will be randomized to genotype-guided dosing versus usual care.
Eligibility
Inclusion Criteria:
- Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
- Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
- Age ≥ 18 years.
- ECOG performance status ≤ 1.
- Patients must have adequate organ and marrow function as defined below:
- Measurable or non-measurable disease.
Exclusion Criteria:
- Patients who received prior treatment with irinotecan are excluded.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
- Pregnant women are excluded from this study.
- Patients who are not planned for treatment of their cancer.