A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

- Metastatic colorectal cancer confirmed by a biopsy sample

- 18 years of age or older

- Evidence of disease progression at time of study entry

- At least one prior adjuvant chemotherapy regimen

- No prior therapy for metastatic disease

- Measurable disease

- Able to perform activities of daily living with minimal assistance

- Adequate bone marrow, kidney, and liver function

- Tumor tissue available for assessment of EGFR

- Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

- Treatment with a previous regimen for metastatic disease

- Prior treatment with any EGFR inhibitor or anti-angiogenic agents

- Brain or nervous system metastases

- History of severe thromboembolic event

- Clinical evidence or history of bleeding or coagulopathy

- History of stroke or heart attack within six months

- Poorly controlled hypertension

- Non-healing wound, ulcer, or bone fracture

- History of abdominal fistula, perforation, or abscess within six months

- Other uncontrolled or significant disease or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have. You can then decide if you wish to
participate.