Actively Recruiting
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Led by Reema A. Patel · Updated on 2025-12-16
178
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 65 18 years.
- ECOG performance status 64 1.
- Patients must have adequate organ and marrow function as defined below:
- Measurable or non-measurable disease.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
R
Reema A Patel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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