A Prospective, Randomized, Open-label Trial Comparing OnDose® AUC Optimized 5-FU Based Administration Versus Standard Body Surface Area (BSA) Dosing in Metastatic Colorectal Cancer Patients (mCRC) Treated With mFOLFOX6

Inclusion Criteria

Selection Criteria:

- Patients with histologically confirmed metastatic colorectal cancer

- No prior chemotherapy for the treatment of metastatic colorectal cancer

- At least one measurable lesion by CT or MRI of ≥ 20 mm (if conventional CT scan) or ≥
10 mm (if spiral CT scan)

- ECOG Performance Status (ECOG-PS) status ≤ 2

- At least 18 years of age

- Life expectancy > 6 months

- Must be able and willing to give written informed consent

- Women of child-bearing potential (i.e., women who are pre-menopausal or not
surgically sterile) must use acceptable contraceptive methods (abstinence,
intrauterine device [IUD], oral contraceptive or double barrier device), and must
have a negative serum or urine pregnancy test within 1 week prior to beginning
treatment on this trial. Nursing patients are excluded. Sexually active men must also
use acceptable contraceptive methods (abstinence, condom).

- ANC count greater than or equal to 1,500/ mm³

- Platelets greater than or equal to 100,000/ mm³

- Serum creatinine less than or equal to 2x upper limit of normal (normal range (male):
97-137 mL/min; (female): 88-128 mL/min)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or
equal to 3x the upper limit of normal (≤ 5.0 x ULN is acceptable if liver has tumor
involvement) (ALT normal range: < 41 iu/L (male), < 31 iu/L (female); AST normal
range: < 37 iu/L (male), < 31 iu/L (female)).

- Prothrombin Time (PT), activated partial thromboplastin time (aPTT) and INR ≤ 1.5 x
ULN (INR normal range: 0.8-1.2) or in the therapeutic range if on anticoagulation.

- Hemoglobin greater than or equal to 9 gm/dl (may be corrected by transfusion prior to
5-FU treatment with investigator approval).