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

ConditionsColorectal CancerPancreatic Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Irinotecan

    Drug

    Usual dosing per package insert.

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Genocare GuidedExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Overall Survival

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Reema A. Patel

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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