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

Reema A. Patel

Status

Enrolling

Conditions

Pancreatic Cancer

Colorectal Cancer

Treatments

Drug: Irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT05391126

MCC-22-GI-125-PMC

Details and patient eligibility

About

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.

Enrollment

178 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.