Pharmacogenetic Testing for Cancer Treatment Safety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Must be taking: Fluoropyrimidine, Irinotecan

Disqualifiers: Bone marrow transplant, Liver transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be evaluating patients suspected to carry DPYD or UGT1A1 variants based off of Michigan Genomics Initiative (MGI) results. Standard of care treatment will be initiated with either Fluoropyrimidine or Irinotecan therapy. Retrospective collection of treatment related AEs and SAEs, dose delays, dose reductions, and treatment discontinuations will be completed.

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.

What data supports the effectiveness of pharmacogenetic testing for cancer treatment safety involving DPYD or UGT1A1 variants?

Research shows that pharmacogenetic testing can help identify patients with genetic variants that increase the risk of severe side effects from cancer drugs like 5-fluorouracil and irinotecan. By knowing these genetic differences, doctors can adjust drug doses to prevent harmful effects, making treatment safer for patients. ^{1 2 3 4 5}

Is pharmacogenetic testing for DPYD and UGT1A1 variants safe for cancer treatment?

Pharmacogenetic testing for DPYD and UGT1A1 variants can help identify patients at risk of severe side effects from certain cancer treatments, like 5-fluorouracil and irinotecan. This testing allows doctors to adjust doses to improve safety and reduce the risk of harmful reactions. ^{1 2 5 6 7}

How does pharmacogenetic testing for DPYD and UGT1A1 variants improve cancer drug safety?

Pharmacogenetic testing for DPYD and UGT1A1 variants helps tailor cancer treatment by identifying patients who may experience severe side effects from certain chemotherapy drugs, like irinotecan and 5-fluorouracil. This allows doctors to adjust drug doses beforehand, reducing the risk of toxicity and improving treatment safety. ^{2 3 6 7 8}

Research Team

Amy Pasternak

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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

I am older than 18 years.

My medication dose was reduced based on genetic test results.

I have a specific genetic marker related to how my body processes certain cancer drugs.

Exclusion Criteria

I have had a liver transplant.

I have been treated with FP due to a suspected DPYD gene issue.

I have been treated with irinotecan due to my specific genetic makeup.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Standard of care treatment initiated with either Fluoropyrimidine or Irinotecan therapy

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• DPYD or UGT1A1 variants

Trial Overview The study tests if patients' genetic makeup (specifically DPYD or UGT1A1 variants) influences side effects when treated with Fluoropyrimidine or Irinotecan. It involves looking back at past treatments and outcomes as well as monitoring new patients starting therapy.

Participant Groups

Group I: Controls Experimental Treatment 0 Interventions

This arm will be compiled of all retrospective patients where genetic information was not known prior to receiving treatment.

Group II: Cases Experimental Treatment 1 Intervention

This arm will be compiled of prospectively recruited cases for confirmatory testing based on their suspected genotype per Michigan Genomics Initiative and patients who have been retrospectively identified as any patient who had clinical genotype testing and had a variant that was their clinician used to guide the chemotherapy treatment. Prospective patients will undergo confirmatory genetic testing by a CLIA lab and those results will be provided to the patients clinical team at that time.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of preemptive pharmacogenetic testing in colorectal cancer patients within a community oncology setting. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Value of Pharmacogenomic Testing in a Patient Receiving FOLFIRINOX for Pancreatic Adenocarcinoma. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Cancer pharmacogenomics: powerful tools in cancer chemotherapy and drug development. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

RS7435335 located in the UGT2B7 gene may be a possible genetic marker for the clinical response and prognosis of breast cancer patients receiving neoadjuvant chemotherapy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

DPYD and UGT1A1 genotyping to predict adverse events during first-line FOLFIRI or FOLFOXIRI plus bevacizumab in metastatic colorectal cancer. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacogenetics testing (DPYD and UGT1A1) for fluoropyrimidine and irinotecan in routine clinical care: Perspectives of medical oncologists and oncology pharmacists. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Predictive role of the UGT1A1, UGT1A7, and UGT1A9 genetic variants and their haplotypes on the outcome of metastatic colorectal cancer patients treated with fluorouracil, leucovorin, and irinotecan. [2021]

8. France pubmed.ncbi.nlm.nih.gov

Pharmacogenetics of anti-cancer drugs: State of the art and implementation - recommendations of the French National Network of Pharmacogenetics. [2017]