Multicenter Study Investigating Utilization of Pharmacokinetic-Guided 5-Fluorouracil in Patients Receiving mFOLFOX6 With or Without Bevacizumab
- To determine whether 4 courses of pharmacokinetic (PK)-guided 5-fluorouracil
chemotherapy improves the ability to achieve a targeted area under the curve (20 to 25
mg*hr/L) in patients with colorectal cancer receiving mFOLFOX6 chemotherapy as compared
to historical non-PK-guided therapy in patients treated with a similar FOLFOX regimen.
- To determine and compare the incidence of neutropenia and diarrhea in patients treated
with these regimens.
OUTLINE: This is a multicenter study.
- Standard mFOLFOX6 (course 1): Patients receive fluorouracil IV bolus over 1-5 minutes
followed by fluorouracil IV continuously over 46 hours, oxaliplatin IV over 2 hours,
and leucovorin calcium IV over 2 hours on day 1.
Patients undergo plasma sample collection periodically during study for pharmacokinetic
(PK)-guided fluorouracil dose determination for courses 2-4.
- PK-guided mFOLFOX6 (courses 2-4): Patients receive fluorouracil bolus, oxaliplatin, and
leucovorin calcium as in course 1. Patients also receive fluorouracil* IV continuously
as determined by the PK-guided analysis.
NOTE: *The continuous infusion fluorouracil dose adjustment is calculated based on the
results of PK plasma concentrations and the corresponding AUC from the preceding course.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Achievement of targeted AUC using pharmacokinetic (PK)-guided 5 fluorouracil as part of mFOLFOX6 therapy
During first 4 cycles of drug therapy
Christine M. Walko, PharmD, BCOP
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|Moses Cone Regional Cancer Center at Wesley Long Community Hospital||Greensboro, North Carolina 27401|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|Rex Cancer Center at Rex Hospital||Raleigh, North Carolina 27607|
|Cancer Care of Western North Carolina||Asheville, North Carolina 28801|
|Marion L. Shepard Cancer Center||Washington, North Carolina|