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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.