GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReema A. Patel
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Irinotecan
Treatment groups
178 Participants
are divided into 2 treatment groupsSponsors and collaborators
Reema A. Patel
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov