GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Genocare Guided
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Drug: Irinotecan
Usual dosing per package insert.
Other Names:
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No Intervention: Usual Care
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Outcome Measures
Primary Outcome Measures
- Adverse Events Frequency [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 Outcome Measures
- Overall Survival [5 years]
To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
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Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
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Age ≥ 18 years.
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ECOG performance status ≤ 1.
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Patients must have adequate organ and marrow function as defined below:
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Measurable or non-measurable disease.
Exclusion Criteria:
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Patients who received prior treatment with irinotecan are excluded.
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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.
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Pregnant women are excluded from this study.
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Patients who are not planned for treatment of their cancer.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Reema A. Patel
Investigators
- Principal Investigator: Reema A Patel, MD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 78068