Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

Exclusion Criteria

• •Pregnant or lactating woman.
• •Life expectancy \< 3 months.
• •Serious, uncontrolled, concurrent infection(s) or illness(es)
• •Any prior oxaliplatin treatment, with the exception of adjuvant therapy given \> 12 months prior to the beginning of study therapy
• •Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency
• •Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
• •Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• •Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
• •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months.
• •History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
• •History of persistent neurosensory disorder including but not limited to peripheral neuropathy.
• •Presence of central nervous system or brain mets.
• •Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
• •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• •Any of the following laboratory values:
• •* Abnormal hematologic values (neutrophils \< 1.5 x 109/L, platelet count \< 100 x 109/L)
• •* Urine protein: creatinine ratio \>/= 1.0 Impaired renal function with estimated creatinine clearance \< 30 ml/min as calculated with Cockroft et Gault equation:
• •* Serum bilirubin \> 1.5 x upper normal limit. ALT, AST \> 2.5 x upper normal limit (or \> 5 x upper normal limit in the case of liver metastases)
• •* Alkaline phosphatase \> 2.5 x upper normal limit (or \> 5 x upper normal limit in the case of liver metastases or \> 10 x upper normal limit in the case of bone disease)
• •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
• •Blood pressure \> 150/100 mmHg
• •Unstable angina
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure
• •History of myocardial infarction or stroke within 6 months
• •Clinically significant peripheral vascular disease
• •Evidence of bleeding diathesis or coagulopathy
• •History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
• •Serious, non-healing wound, ulcer or bone fracture
• •Carcinoma of any histology in close proximity to a major vessel, cavitation or history of hemoptysis.
• •Completion of previous adjuvant chemotherapy regimen \< four weeks prior to the start of study treatment (within six weeks of study treatment for mitomycin C and nitroureas), or with related toxicities unresolved prior to the start of study treatment.