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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391126
• Other study ID #: MCC-22-GI-125-PMC
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: Reema A Patel, MD
• Phone: 8592186650
• Email: reema.patel[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Pancreatic Cancer

Intervention

Drug:
• Irinotecan
Usual dosing per package insert.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Reema A. Patel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events Frequency	To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a *1/*28 or *1/*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care.	6 months
Secondary	Overall Survival	To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.	5 years