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NCT Number: NCT05391126

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Irinotecan

Drug

Usual dosing per package insert.

Other names: Nano-liposomal Irinotecan, Onyvide

Primary outcomes

  1. Adverse Events Frequency

    Time frame: 6 months

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

    To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Reema A. Patel

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 25, 2022
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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