Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer

Inclusion Criteria

• Are male or female aged 18-75 years at the time of signing the informed consent form.
• Have been diagnosed as mCRC verified histologically
• Having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria,
• Was not felt to be amenable to curative resection,
• With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Life expectancy of longer than 3 months ( clinical assessment)
• Adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) greater than/equal to 1,500/mm3;
• Platelets greater than/equal to 100,000/ mm3;
• Hemoglobin greater than/equal to 9 gm/dl (may be transfused to maintain or exceed this level);
• Total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
• Aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) less than/equal to 2.5 times IULN, or less than/equal to 5 times IULN if known liver metastases;
• May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented
• Patients with history of hypertension must be well-controlled (blood pressure less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.

Exclusion Criteria

• Prior targeted therapy for mCRC
• Radiotherapy or surgery for mCRC less than 4 weeks before random assignment.
• Undergone major surgical procedures or open biopsy within 28 days before the initiation of study treatment
• Experienced significant traumatic injury, within 28 days before study entry
• Currently using or had recently used therapeutic anticoagulants, thrombolytic therapy, chronic, daily treatment with aspirin (higher than 325 mg/daily). (Patients may have prophylactic use of low molecular weight heparin, however therapeutic use of heparin or low molecular weight heparin is not acceptable)
• Proteinuria exceeding 500mg/24 h
• History or presence of central nervous system metastases
• Female patients who are pregnant or lactating
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin
• Serious non-healing wound, ulcer, or active bone fracture
• Myocardial infarction within 6 months before of study enrollment;
• History of stroke within 6 months before of study enrollment;
• Clinically significant peripheral vascular disease;
• Uncontrolled diabetes; Serious active or uncontrolled infection
• Inability to comply with study and/or follow-up procedures