GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

Summary

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.

Conditions3

Interventions1

Locations1 site

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