A Genotype-guided Dosing Study of mFOLFIRINOX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies
I. To determine the dose-limiting toxicity (DLT) rate in cycle #1 in each of two UGT1A1
genotype groups (*1*1, *1*28) using genotype-guided dosing of irinotecan as part of the
modified (m) FOLFIRINOX regimen.
I. To determine the cumulative dose intensity of irinotecan achieved in each genotype group.
II. To determine the response rates by Response Evaluation Criteria in Solid Tumors (RECIST)
(version 1.1) for each different disease (pancreatic cancer, biliary cancers, gastric
cancer, colorectal cancer, adenocarcinoma of unknown primary) treated in the study.
Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV
over 1.5 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46
hours on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence
of disease progression or unacceptable toxicity.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
DLT rate in course 1 for each of the two most common genotype groups (*1*1 and *1*28)
To show that the DLT rate is less than 33% with at least 70-80% confidence, which is comparable to the standard 3+3 phase I design with 0 out of 3 or 1 out of 6 patients experiencing a DLT.
University of Chicago Comprehensive Cancer Center
United States: Institutional Review Board
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|