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

NCT05391126 | Recruiting DMC

• 1 other identifier: MCC-22-GI-125-PMC
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  5 years

Study Arms (2)

Genocare Guided

EXPERIMENTAL

Drug: Irinotecan

Usual Care

NO INTERVENTION

Interventions

Irinotecan DRUG

Usual dosing per package insert.

Also known as: Nano-liposomal Irinotecan, Onyvide

Genocare Guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reema A. Patel: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Reema A Patel, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reema A Patel, MD

CONTACT

8592186650; reema.patel@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: September 28, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)