Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer

Exclusion Criteria

• •Had prior chemotherapy for metastatic colorectal cancer
• •Received any prior treatment with oxaliplatin, bevacizumab, or cetuximab in the adjuvant treatment of their colorectal cancer
• •Currently receiving any other investigational anticancer agents or has participated in an experimental drug study within the past 4 weeks
• •History of primary CNS tumors, seizures not well-controlled with standard medical therapy, or stroke
• •Sustained hypertension, as characterized by persistent blood pressures greater than 150/100 despite medical management
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure or has had angioplasty or placement of coronary stents within the past 6 months
• •Clinically significant peripheral vascular disease
• •History of serious allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, cetuximab, oxaliplatin, fluorouracil, leucovorin, or other agents used in the study
• •Received prior cetuximab or other EGFR-directed therapy, or history of prior anti-cancer murine or chimeric monoclonal antibody therapy; prior humanized and human monoclonal antibody therapy is also excluded.
• •Received prior treatment with bevacizumab or other agents specifically targeting VEGF or VEGF receptors
• •Uncontrolled intercurrent illness including, not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the Investigator/Treating Physician
• •Serious or non-healing active wound ulcer, or active bone fracture
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of protocol treatment
• •Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
• •Current or recent use of a thrombolytic agent within last 30 days. Use for clearance of central line catheter is permitted.
• •Evidence of bleeding diathesis (disorder) or clinically significant coagulopathy (Note that deep venous thrombosis is not regarded as a reason for exclusion from this trial)
• •Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• •History of arterial thromboembolic events within 6 months
• •Urine protein:creatinine ratio greater than 1.0 at screening
• •Pregnant or lactating woman
• •Known to be HIV positive or receiving combination anti-retroviral therapy
• •Unable to comply with study requirements