Multicenter Study Investigating Utilization of Pharmacokinetic-Guided 5-Fluorouracil in Patients Receiving mFOLFOX6 With or Without Bevacizumab
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
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
No
Christine M. Walko, PharmD, BCOP
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
LCCC 0918
NCT01164215
February 2010
August 2015
Name | Location |
---|---|
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 |