GENOCARE: A Prospective, Randomized Clinical Trial Of Genotype-Guided Dosing Versus Usual Care

Study Overview

GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (*1/*28) (heterozygotes) and usual UGT metabolizers (*1/*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (*1/*28, *1/*1) will be randomized to genotype-guided dosing versus usual care.

N/A

Colorectal Cancer
Pancreatic Cancer

DRUG: Irinotecan

MCC-22-GI-125-PMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-10-06
First Submitted that Met QC Criteria 2022-05-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-10
First Posted (ACTUAL) 2022-05-25	Results First Posted N/A	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Genocare Guided	DRUG: Irinotecan Usual dosing per package insert.
NO_INTERVENTION: Usual Care

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Genocare Guided

DRUG: Irinotecan

Usual dosing per package insert.

NO_INTERVENTION: Usual Care

Primary Outcome Measures	Measure Description	Time Frame
Adverse Events Frequency	To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a 1/28 or 1/1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care.	6 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival	To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.	5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Reema A Patel, MD

Phone Number: 8592186650

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
Age ≥ 18 years.
ECOG performance status ≤ 1.
Patients must have adequate organ and marrow function as defined below:
Measurable or non-measurable disease.

Patients who received prior treatment with irinotecan are excluded.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
Pregnant women are excluded from this study.
Patients who are not planned for treatment of their cancer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Reema A Patel, MD, University of Kentucky

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record