Fluorouracil injection: Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
Xeloda: Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
incidence of severe fluoropyrimidine-related toxicities (Grade 3-5) — up to 24 months Number and proportion of patients experiencing Grade 3, 4, or 5 toxicities related to 5-FU or Capecitabine, as defined by CTCAE v5.0.
Trial sites (12)
Facility
City
Region
Status
RWJBarnabas Health Clara Maas Medical Center
Belleville
New Jersey
Recruiting
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth
New Jersey
Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton
New Jersey
Recruiting
RWJBarnabas Health Jersey City Medical Center
Jersey City
New Jersey
Recruiting
Cooperman Barnabas Medical Center
Livingston
New Jersey
Recruiting
Jack and Sheryl Morris Cancer Center
New Brunswick
New Jersey
Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospita
New Brunswick
New Jersey
Recruiting
Cancer Center Initiative
Newark
New Jersey
Recruiting
University Hospital
Newark
New Jersey
Recruiting
RWJBarnabas Health Newark Beth Israel Medical Center
Newark
New Jersey
Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville
New Jersey
Recruiting
RWJBarnabas Health - Community Medical Center
Toms River
New Jersey
Recruiting
More Rutgers, The State University of New Jersey trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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