Breast Cancer, Dihydropyrimidine Dehydrogenase Deficiency, Gastrointestinal Cancer, Head and Neck Cancer, UGT1A1 Gene Mutation
Conditions
Keywords
Pharmacogenomics
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".
Interventions
OTHERAvailability of clinical decision support based on pharmacogenomic results.
Availability of clinical decision support based on pharmacogenomic results. These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
Sponsors
University of Chicago
National Human Genome Research Institute (NHGRI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Deviation Rate (Co-Primary Endpoint) | 15 months | To assess the impact of prospective pharmacogenomic testing on dose intensity deviation rate of chemotherapy during the 1st treatment cycle, comparing control vs. pharmacogenomics-guided arms. |
| Grade 3 or Higher Toxicity (Co-Primary Endpoint) | 5 years | To determine the degree to which providing oncologists with comprehensive pharmacogenomic information impacts the incidence of Grade 3 or worse toxicities in subjects receiving chemotherapy. Toxicities will be assessed by Common Terminology Criteria for Adverse Events version 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Chemotherapy Dose Intensity | 5 years. | Cumulative drug dose intensity received (function of dose and frequency of drug administration). |
| Response Rate | 5 years. | Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting. |
| Progression free survival (PFS) | 5 years | Progression free survival (PFS) by tumor type and disease setting. |
| Overall Survival | 5 years | Overall survival (OS) by tumor type and disease setting. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter H. O'Donnell, MD
University of Chicago
Outcome results
None listed