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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Pancreatic Cancer
• Interventions: Drug: Irinotecan

• Registration Number: NCT05391126
• Lead Sponsor: Reema A. Patel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Start: 2022-09-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genocare Guided	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
Adverse Events Frequency	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States