DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY ·

Keywords

ClinConnect Summary

This study tests whether using a patient’s DPYD gene test to guide chemo dosing can lower the risk of serious side effects from common stomach/intestinal cancer drugs (5-FU and Capecitabine) when these drugs are used for colorectal, breast, head-and-neck, or other GI cancers. In this non-randomized, parallel trial, people with one DPYD gene variant (heterozygotes) will start at half the usual dose for the first two treatment cycles and may increase if tolerated, while people with normal DPYD will receive the standard starting dose with usual safety adjustments for any toxicity. The main goal is to compare how many patients in each group experience severe (Grade 3–5) toxicities within 24 months, with secondary data on how often doses need to be reduced, increased, or stopped.

Eligible adults 18 and older who are starting 5-FU or Capecitabine and have DPYD testing already done or will have it done before starting therapy can join. Key inclusion includes diagnosis of an eligible cancer and a DPYD test result placing them in the heterozygote or normal-DPYD group; two DPYD variants or pregnancy are exclusions. The study plans to enroll about 100 participants at multiple New Jersey sites, but it is not recruiting yet (start and completion dates are estimated). If you’re considering this, talk with your oncologist about whether DPYD testing and dose-guided dosing could be right for you. For more information, you can contact the study team lead, Dr. Howard S. Hochster.

Gender

ALL

Eligibility criteria