The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Breast Cancer Clinical Trial

Official title:

The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541381
• Other study ID #: IRB20-0462
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: March 31, 2028

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Peter H. O'Donnell, MD
• Phone: 773-834-0936
• Email: podonnel[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: March 31, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Head and Neck Cancer

Intervention

Other:
• Availability 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Deviation Rate (Co-Primary Endpoint)	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.	15 months
Primary	Grade 3 or Higher Toxicity (Co-Primary Endpoint)	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.	5 years
Secondary	Cumulative Chemotherapy Dose Intensity	Cumulative drug dose intensity received (function of dose and frequency of drug administration).	5 years.
Secondary	Response Rate	Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting.	5 years.
Secondary	Progression free survival (PFS)	Progression free survival (PFS) by tumor type and disease setting.	5 years
Secondary	Overall Survival	Overall survival (OS) by tumor type and disease setting.	5 years