Colorectal Cancer, Pancreatic Cancer
Conditions
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.
Interventions
DRUGIrinotecan
Usual dosing per package insert.
Sponsors
Reema A. Patel
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactReema A Patel, MD
Outcome results
None listed