Genotype-guided dosing for cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.