RecruitingNot ApplicableNCT05391126

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

Sponsor

Reema A. Patel

Enrollment

178 participants

Start Date

Sep 28, 2022

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Pancreatic Cancer

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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.