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

Purpose

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.

Conditions

  • Colorectal Cancer
  • Pancreatic Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Genocare Guided
  • Drug: Irinotecan
    Usual dosing per package insert.
    Other names:
    • Nano-liposomal Irinotecan
    • Onyvide
No Intervention
Usual Care

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Yvonne Taul
859-323-2354
Yvonne.Taul@uky.edu

More Details

NCT ID
NCT05391126
Status
Recruiting
Sponsor
Reema A. Patel

Study Contact

Reema A Patel, MD
8592186650
reema.patel@uky.edu