Pharmacogenetic Testing for Cancer Treatment Safety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how genes impact the safety and effectiveness of cancer treatments with Fluoropyrimidine or Irinotecan. Researchers aim to understand how certain genetic traits might affect treatment outcomes, such as side effects or the need for dose changes. The trial involves two groups: those with known genetic traits and those without this genetic information. It suits individuals with cancer who are starting or have already started treatment with these drugs, especially if genetic testing has identified specific traits linked to treatment response, such as DPYD or UGT1A1 variants.
As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it focuses on starting treatment with specific cancer drugs, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that testing for specific genetic markers, DPYD and UGT1A1, before treatment can enhance patient safety. These tests enable doctors to adjust doses of chemotherapy drugs like fluoropyrimidine and irinotecan. Studies indicate that using these tests to guide treatment reduces drug side effects for patients.
Testing before chemotherapy, for example, has been proven to lessen side effects without compromising treatment effectiveness. This approach allows patients to receive effective cancer care more safely. Additionally, real-world evidence supports that these tests significantly improve patient safety.
In summary, genetic testing to guide chemotherapy dosing offers a promising way to make cancer treatment safer.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it uses pharmacogenetic testing to tailor cancer treatments based on individual genetic variants, specifically DPYD and UGT1A1. Unlike standard chemotherapy, which is often a one-size-fits-all approach, this method personalizes treatment plans, potentially reducing harmful side effects and improving effectiveness. By identifying genetic variants that affect drug metabolism, clinicians can adjust dosages or select alternative therapies, making cancer treatment safer and more effective for each patient. This personalized approach marks a significant advancement in precision medicine, aiming to optimize therapeutic outcomes while minimizing risks.
What evidence suggests that this trial's treatments could be effective for cancer treatment safety?
Research shows that testing for certain genetic differences, called DPYD and UGT1A1 variants, can make chemotherapy treatments safer. This trial includes two arms: the "Cases" arm, where participants undergo confirmatory genetic testing to guide chemotherapy treatment, and the "Controls" arm, consisting of patients who receive treatment without prior genetic information. Studies have found that genetic testing helps adjust the chemotherapy dose, reducing side effects by half for patients with gastrointestinal (GI) cancers. Specifically, changes in the DPYD gene link to severe side effects from fluoropyrimidine, a common chemotherapy drug. Adjusting doses based on these genetic tests improves safety without reducing treatment effectiveness. This personalized approach ensures patients receive the most effective dose while minimizing harm.36789
Who Is on the Research Team?
Amy Pasternak
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with cancer who may have genetic variants (DPYD or UGT1A1) that could affect how they respond to chemotherapy drugs like Fluoropyrimidine or Irinotecan. Participants must understand and consent to the study. Those previously treated with these drugs, unable to consent, or with a history of certain transplants are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Standard of care treatment initiated with either Fluoropyrimidine or Irinotecan therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DPYD or UGT1A1 variants
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor