Genotype-guided dosing for cancer treatment
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
This study is testing if giving cancer patients a personalized dose of irinotecan based on their genetics can lead to better treatment results than the usual dosing method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05391126 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares genotype-guided dosing of irinotecan to usual care in patients with stage I-IV pancreatic or stage III-IV colorectal cancer who are UGT1A1 intermediate metabolizers or usual metabolizers. Patients will be screened for their UGT1A1 genotype and those eligible will be randomized to receive either the genotype-guided dosing or standard treatment. The goal is to determine if personalized dosing based on genetic makeup improves treatment outcomes compared to conventional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage I-IV pancreatic or stage III-IV colorectal cancer who are UGT1A1 intermediate or usual metabolizers.
Not a fit: Patients who have previously received irinotecan or are not planned for cancer treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized cancer treatment for patients based on their genetic profiles.
How similar studies have performed: Other studies have shown promise in using genotype-guided dosing for cancer therapies, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Reema A Patel, MD — University of Kentucky
- Study coordinator: Reema A Patel, MD
- Email: reema.patel@uky.edu
- Phone: 8592186650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.