Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen

Inclusion Criteria

Inclusion Criteria

- Metastatic colorectal cancer

- Tumor classified WT KRAS

- At least 18 yrs of age

- ECOG PS 0,1 or 2

- Evidence of adequate organ function

- Measurable disease per RECIST criteria

- Have at least two of the following criteria:

- Age > 65 years

- ECOG PS 1 or 2

- Serum Albumin < or equal to 3.5g/dL

- Prior RT to abdomen or pelvis

- Stopped first-line combination systemic chemotherapy < 6 weeks duration

Exclusion Criteria

- Tumors classified as KRAS mutation

- Prior therapy with cetuximab, panitumumab or other agent that targets EGFR

- Prior exposure to any biologic

- Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)

- Known DPD deficiency

- Uncontrolled angina or a myocardial infarction within the previous 12 months

- Concurrent severe uncontrolled medical illness

- Known uncontrolled CNS metastases

- Bowel disease associated with chronic diarrhea

- Major surgery within 28 days