DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Recruiting · NCT07158164 · Interventional (participants receive a specific treatment) · Lead sponsor: Rutgers, The State University of New Jersey
View the official record on ClinicalTrials.gov →Interventions studied
Fluorouracil injectionXeloda
What this trial is about
To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine.
- DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy.
- DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine:
- Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).
- Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.
- FOLFOX regimen (N=50)
- ECOG Performance Status 0-2.
- Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.
Exclusion criteria
- Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician.
- Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study.
- Pregnant Women and Children
Where it is running
12 locations listed across 1 US state.
- RWJBarnabas Health Clara Maas Medical Center - Belleville, New Jersey, United States
- Trinitas Hospital and Comprehensive Cancer Center - Elizabeth, New Jersey, United States
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton - Hamilton, New Jersey, United States
- RWJBarnabas Health Jersey City Medical Center - Jersey City, New Jersey, United States
- Cooperman Barnabas Medical Center - Livingston, New Jersey, United States
- Jack and Sheryl Morris Cancer Center - New Brunswick, New Jersey, United States
- RWJBarnabas Health - Robert Wood Johnson University Hospita - New Brunswick, New Jersey, United States
- Cancer Center Initiative - Newark, New Jersey, United States
- University Hospital - Newark, New Jersey, United States
- RWJBarnabas Health Newark Beth Israel Medical Center - Newark, New Jersey, United States
- RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset - Somerville, New Jersey, United States
- RWJBarnabas Health - Community Medical Center - Toms River, New Jersey, United States