RECRUITINGPhase 4INTERVENTIONAL
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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)
- You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2.
- Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Fluorouracil injection
Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
DRUG
Xeloda
Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
Locations (12)
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