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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40506

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Reema A. Patel,

Reema A Patel, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2027-05