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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed colorectal cancer

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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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