Clinical trial NCT04541381: The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care
Official title: The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Head and Neck Cancer
Dihydropyrimidine Dehydrogenase Deficiency
UGT1A1 Gene Mutation
Breast Cancer
Keywords: Pharmacogenomics
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. Doctors leading the study will collect genetic information from study participants using pharmacogenomics/genotyping. Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications.

This is a randomized study, which means that participants in this study will be randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".


Eligibility criteria: Inclusion Criteria Adult patients receiving oncology care at The University of Chicago Medical Center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned are eligible.

Individuals of all genders, races and ethnic groups are eligible for this trial. There is no bias towards race, sex, or gender in the clinical trial outlined.

Exclusion Criteria

1. Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan).
2. Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies.
3. Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
4. Subjects with a history of or active blood cancer (e.g., leukemia).
5. Chronic kidney disease, as defined by glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
6. Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin more than 1.5 mg/dL, aspartate Aminotransferase (AST) and alanine transaminase (ALT) more than 2.5 X upper limit of normal\*. (\*AST and ALT more than 5 X upper limit of normal if hepatic metastases are present).
7. Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
8. Inability to understand and give informed consent to participate.

Primary outcomes:
measure: Dose Deviation Rate (Co-Primary Endpoint)
timeFrame: 15 months
measure: Grade 3 or Higher Toxicity (Co-Primary Endpoint)
timeFrame: 5 years
Secondary outcomes:
measure: Cumulative Chemotherapy Dose Intensity
timeFrame: 5 years.
measure: Response Rate
timeFrame: 5 years.
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Peter H. O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: