Biomarker-Guided Fluorouracil in Treating Patients With Colorectal Cancer Receiving Combination Chemotherapy

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