What this study is
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.
What's being tested
- Irinotecan
Intervention · DRUG
Usual dosing per package insert.
Study details
- Sponsor
- Reema A. Patel
- Conditions
- Colorectal Cancer · Pancreatic Cancer
- Enrolling
- 178 people
- Starts
- 2022-09-28
- Est. completion
- 2027-05
- Design
- Single-blind, randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kentucky
Lexington, Kentucky, United States
- Yvonne Taul · Contact859-323-2354Yvonne.Taul@uky.edu
Recruiting
Study team
Sponsor
Reema A. Patel
Study ID MCC-22-GI-125-PMC
Principal investigator
Reema A Patel, MD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.