Study on Adjusting Fluoropyrimidine (FP) Doses Based on DPYD Gene Testing
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT07158164
This clinical trial is exploring whether adjusting the doses of certain chemotherapy drugs based on genetic testing can reduce severe side effects in patients with cancer. The study focuses on patients with a specific genetic variant that affects how their body processes these drugs.
Patient Parameters
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Program Overview
The study aims to find out if using genetic testing to guide the dosing of chemotherapy drugs like 5-Fluorouracil (5-FU) and Capecitabine can help reduce severe side effects in patients with cancer. These drugs are commonly used to treat various cancers, but some patients experience serious side effects due to a genetic variant that affects the DPD enzyme, which helps break down these drugs in the body. By adjusting the doses based on genetic testing, researchers hope to make the treatment safer and more effective.
Description
Fluoropyrimidines, such as 5-Fluorouracil (5-FU) and Capecitabine, are important chemotherapy drugs used to treat different types of cancer, including those affecting the digestive system, head and neck, and breast. However, the right dose can be tricky because some patients experience severe side effects due to differences in how their bodies process these drugs. This is often due to a deficiency in an enzyme called DPD, which helps break down the drugs into less harmful substances.
Genetic testing can identify variants in the DPYD gene that affect DPD enzyme activity. People with certain variants may have reduced or no enzyme function, leading to higher risk of side effects. This study is testing whether adjusting the drug doses based on these genetic test results can help reduce severe side effects while still effectively treating the cancer.
In the past, routine genetic testing for DPYD variants wasn't common in the U.S. due to cost and other concerns, but it's more common in Europe. Recently, the FDA recommended considering genetic testing for all patients before starting treatment with these drugs. This study will help determine if dose adjustments based on genetic testing are beneficial in a real-world setting.
Eligibility Criteria
Inclusion Criteria
- Have a cancer diagnosis that requires treatment with 5-FU or Capecitabine, either as initial therapy or for advanced cancer.
- Have undergone DPYD genetic testing at a certified lab, with results available before starting chemotherapy.
- Be part of one of the following groups for first-line therapy with a fluoropyrimidine:
- Study Group: Patients with one DPYD variant (heterozygotes).
- Control Group: Patients with normal DPYD genes, receiving the standard dose.
- Have an ECOG Performance Status of 0 to 2, indicating good overall health.
- Have measurable or non-measurable disease, including those receiving adjuvant 5-FU-based regimens.
Exclusion Criteria
- Cannot receive 5-FU or Capecitabine due to medical reasons as determined by the doctor.
- Have two DPYD variants (homozygous or double heterozygotes), as they should not receive 5-FU or Capecitabine.
- Pregnant women and children are not eligible for the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| RWJBarnabas Health Clara Maas Medical Center | 07109 | Belleville | New Jersey |
| Trinitas Hospital and Comprehensive Cancer Center | 07202 | Elizabeth | New Jersey |
| RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton | 08690 | Hamilton | New Jersey |
| RWJBarnabas Health Jersey City Medical Center | 07302 | Jersey City | New Jersey |
| Cooperman Barnabas Medical Center | 07039 | Livingston | New Jersey |
| Jack and Sheryl Morris Cancer Center | 08901 | New Brunswick | New Jersey |
| RWJBarnabas Health - Robert Wood Johnson University Hospita | 08903 | New Brunswick | New Jersey |
| Cancer Center Initiative | 07103 | Newark | New Jersey |
| University Hospital | 07103 | Newark | New Jersey |
| RWJBarnabas Health Newark Beth Israel Medical Center | 07112 | Newark | New Jersey |
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