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Multicenter Study Investigating Utilization of Pharmacokinetic-Guided 5-Fluorouracil in Patients Receiving mFOLFOX6 With or Without Bevacizumab

Phase 1
Open (Enrolling)
Colorectal Cancer, Diarrhea, Neutropenia

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Trial Information

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.

Inclusion Criteria


- Histologically confirmed colorectal cancer

- Patients scheduled to receive mFOLFOX6 (in the adjuvant setting or for metastatic
disease) as part of their chemotherapy regimen


- ECOG performance status 0-2

- Life expectancy > 6 months

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Serum creatinine ≤ 1.5 mg/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)

- Fertile patients must use effective contraception

- Negative pregnancy test

- Not pregnant or nursing

- No serious concomitant systemic disorders, including active infection that, in the
opinion of the investigator, would compromise the patient's safety or ability to
complete the study

- No altered mental status precluding understanding of the informed consent process
and/or completion of the necessary studies

- Must be able to follow protocol requirements and give informed consent


- See Disease Characteristics

- Concurrent bevacizumab allowed

- No concurrent warfarin (Coumadin®)

- Concurrent enoxaparin (Lovenox®) allowed

- No concurrent theophylline or aminophylline

- No chocolate beginning 12 hours before day 1 of each course and through the end of
that course's fluorouracil continuous IV

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Achievement of targeted AUC using pharmacokinetic (PK)-guided 5 fluorouracil as part of mFOLFOX6 therapy

Outcome Time Frame:

During first 4 cycles of drug therapy

Safety Issue:


Principal Investigator

Christine M. Walko, PharmD, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

LCCC 0918



Start Date:

February 2010

Completion Date:

August 2015

Related Keywords:

  • Colorectal Cancer
  • Diarrhea
  • Neutropenia
  • neutropenia
  • diarrhea
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms
  • Diarrhea
  • Neutropenia



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