The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Overview

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

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.