Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma

Inclusion Criteria:

- Patients with stage II- IV Colorectal Cancer

- Patients must be 40 years and older

- Patients may be of any race and either gender

- Signed Informed Consent

Patient characteristics:

- Age: 40 years and older

- Sex: Both

- Performance status: Not specified

- Life expectancy: Not specified

Hematopoietic:

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- No history of significant bleeding events within the past 6 months

Hepatic:

- Bilirubin ≤ 1.5 mg/dL

- Albumin ≥ 2.5 g/dL

Renal:

- Creatinine ≤ 1.5 times upper limit of normal

- Protein < 1+ by urinalysis

- Protein < 1 g by 24-hour urine collection

Cardiovascular:

- No conduction defect in heart

- No congestive heart failure

- No myocardial infarction within last 6 months

- No cerebrovascular accident

- No uncontrolled hypertension

- No clinically significant peripheral artery disease

Pulmonary:

- No pulmonary embolism

- No interstitial pneumonia

- No extensive or symptomatic interstitial fibrosis of the lung

Neurologic:

- No uncontrolled seizure disorder

- No active neurological disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

Exclusion Criteria:

- Age below 40 years

- Brain or nervous system metastases

- Any current mental illness

- Hemoglobin is less than 9.0 g/dl

- CBC results are below normal range

- Patients with Hepatitis B or C or who are HIV positive

- Pregnant or nursing patients are not eligible for entry into the study

- Hepatic abnormality AST/ALT > 4 folds