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The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Primary Purpose

Gastrointestinal Cancer, Head and Neck Cancer, Dihydropyrimidine Dehydrogenase Deficiency

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Availability of clinical decision support based on pharmacogenomic results.

About this trial

This is an interventional other trial for Gastrointestinal Cancer focused on measuring Pharmacogenomics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan).
Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies.
Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
Subjects with a history of or active blood cancer (e.g., leukemia).
Chronic kidney disease, as defined by glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
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).
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.
Inability to understand and give informed consent to participate.

Sites / Locations

University of Chicago Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Pharmacogenomics Group

Arm Description

Participants assigned to the control group will receive standard chemotherapy without their doctors receiving any genetic information based on the participants' pharmacogenetic results. DNA (Deoxyribonucleic acid) samples for participants in this group will be stored and tested for genotyping six months later after treatment (or earlier if the participant experiences side effects).

Participants enrolled in the pharmacogenomics group will give a DNA (deoxyribonucleic acid) sample for immediate pharmacogenomic genotyping. Once the genotyping results are in, cancer doctors caring for each participant will have immediate access to clinical decision support based on the participant's genetic results and can make dosing decisions/changes to the participant's chemotherapy prescription.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Cumulative Chemotherapy Dose Intensity

Cumulative drug dose intensity received (function of dose and frequency of drug administration).

Response Rate

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)

Progression free survival (PFS) by tumor type and disease setting.

Overall Survival

Overall survival (OS) by tumor type and disease setting.

Full Information

NCT ID

NCT04541381

First Posted

September 1, 2020

Last Updated

October 20, 2022

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04541381

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2022 (Actual)

Primary Completion Date

October 1, 2027 (Anticipated)

Study Completion Date

March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Cancer, Head and Neck Cancer, Dihydropyrimidine Dehydrogenase Deficiency, UGT1A1 Gene Mutation, Breast Cancer

Keywords

Pharmacogenomics

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Blinded

Allocation

Randomized

Enrollment

860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Arm Title

Pharmacogenomics Group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Availability of clinical decision support based on pharmacogenomic results.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dose Deviation Rate (Co-Primary Endpoint)

Description

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.

Time Frame

15 months

Title

Grade 3 or Higher Toxicity (Co-Primary Endpoint)

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Cumulative Chemotherapy Dose Intensity

Description

Cumulative drug dose intensity received (function of dose and frequency of drug administration).

Time Frame

5 years.

Title

Response Rate

Description

Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting.

Time Frame

5 years.

Title

Progression free survival (PFS)

Description

Progression free survival (PFS) by tumor type and disease setting.

Time Frame

5 years

Title

Overall Survival

Description

Overall survival (OS) by tumor type and disease setting.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan). Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies. Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation. Subjects with a history of or active blood cancer (e.g., leukemia). Chronic kidney disease, as defined by glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion. 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). 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. Inability to understand and give informed consent to participate.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter H. O'Donnell, MD

Phone

773-834-0936

podonnel@medicine.bsd.uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter H. O'Donnell, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter H. O'Donnell, MD

Phone

773-834-0936

podonnel@medicine.bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

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