This phase II trial tests how well giving a reduced dose of fluoropyrimidine works to reduce side effects for patients with heterozygous DPYD deficiency who are receiving 5-fluorouracil or capecitabine for cancer treatment. Fluoropyrimidines, like 5-fluorouracil (5-FU) and capecitabine, are common chemotherapy drugs used for many cancers. However, the amount of the drug that causes side effects can vary greatly among patients. A small number of patients experience severe, sometimes life-threatening, side effects because they have a deficiency in an enzyme called dihydropyrimidine dehydrogenase (DPYD). This enzyme is made by the DPYD gene and helps break down 5-FU into less harmful substances. Giving a reduced dose of fluoropyrimidines may work to reduce side effects for patients with heterozygous DPYD deficiency who are receiving 5-fluorouracil or capecitabine for cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07158164.
Locations matching your search criteria
United States
New Jersey
Belleville
Clara Maass Medical CenterStatus: Active
Contact: Benjamin Freeman
Phone: 973-450-2000
Elizabeth
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street CampusStatus: Active
Contact: Gerardo Capo
Phone: 201-915-2000
Hamilton
The Cancer Institute of New Jersey HamiltonStatus: Active
Contact: Meera Yogarajah
Phone: 609-631-6360
Jersey City
Jersey City Medical CenterStatus: Active
Contact: Allan Louie Espino Cruz
Phone: 201-915-2000
Livingston
Saint Barnabas Medical CenterStatus: Active
Contact: Sirish Dharmapuri
Phone: 973-322-5000
Long Branch
Monmouth Medical CenterStatus: Active
Contact: Seth D. Cohen
Phone: 732-222-1711
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Howard S. Hochster
Phone: 732-235-5912
Newark
Newark Beth Israel Medical CenterStatus: Active
Contact: Sari Jacoby
Phone: 973-926-7230
Somerville
Robert Wood Johnson University Hospital SomersetStatus: Active
Contact: Eshan Patel
Phone: 908-927-8702
Toms River
Community Medical CenterStatus: Active
Contact: Seth D. Cohen
Phone: 732-505-1500
PRIMARY OBJECTIVE:
I. Dose modification and safety of patients with one DPYD genetic variant (heterozygous DPYD deficiency) when starting at reduced fluoropyrimidine doses.
SECONDARY OBJECTIVES:
I. To characterize the continued doses used in heterozygous patients with DPYD variants and their ability to increase or necessitate further dose decreases.
II. To characterize the specific grade and nature of fluoropyrimidine-related toxicity in all patient cohorts.
III. To determine time to progression (TTP) on first fluoropyrimidine treatment for all patients.
IV. To compare the rate of fluoropyrimidine dose reductions and dose intensity between DPYD variant patients and normal control patients.
OUTLINE: Patients undergo DPYD testing. Patients with normal DPYD results are assigned to arm I, patients with one DPYD variant (heterozygous) are assigned to arm II, patients with two DPYD variants are ineligible.
ARM I: Patients receive standard of care chemotherapy with standard dosing of 5-FU or capecitabine in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection during screening and computed tomography (CT) scan, with or without positron emission tomography (PET) scan throughout the study.
ARM II: Patients receive standard of care chemotherapy with a reduced dose of 5-FU or capecitabine in the absence of disease progression or unacceptable toxicity. If patients experience no significant toxicity after 2 cycles the dose may be escalated per the treating physician. If after another 2 cycles patients experience no significant toxicity the dose may be escalated to the standard of care dose, per the treating physician. Patients undergo blood sample collection during screening and CT scan, with or without PET scan throughout the study.
After completion of study treatment, patients are followed up at 20 days and every 3 months for 24 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorHoward S. Hochster
