GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
About this study
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.
- Condition
- Colorectal Cancer, Pancreatic Cancer
- Tested
- Irinotecan
- Sponsor
- Reema A. Patel
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Colorectal Cancer, Pancreatic Cancer
- 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 4
- 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.
Where
1 site, 1 recruiting
University of Kentucky
Lexington, Kentucky, United States
Contact
-
Reema A Patel, MD
8592186650 reema.patel@uky.edu
Potential match only. Final eligibility is determined by the study team.