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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment.

Study Objectives:

Primary Endpoint
- Dose modification and safety of patients with one DPYD genetic variant (heterozygous DPYD deficiency) when starting at reduced fluoropyrimidine doses.

Secondary Endpoints
- To characterize the continued doses used in heterozygous patients with DPYD variants and their ability to increase or necessity to decrease doses further.

- To characterize the specific grade and nature of fluoropyrimidine-related toxicity in all patient cohorts.

- To determine Time to Progression (TTP) on first fluoropyrimidine treatment for all patients.

- To compare rates of fluoropyrimidine dose reductions and dose intensity between DPYD variant patients and normal control patients.

Protocol Number: 072504
Phase: N/A
Applicable Disease Sites: Colon
Esophagus
Larynx
Lip, Oral Cavity and Pharynx
Other Digestive Organ
Pancreas
Rectum
Small Intestine
Stomach
Principal Investigator: Howard Hochster
Scope: Local
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Clara Maass Medical Center
    • Cooperman Barnabas, Livingston
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
    • Trinitas Hospital and Comprehensive Cancer Center
  • Rutgers University

For further information about clinical trials, please contact us at 732-235-7356.