Protocol GI-04A PHASE II TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CAPECITABINE (XELODA) IN FRAIL PATIENTS WITH UNTREATED METASTATIC COLORECTAL CANCER

Primary objectives: •To determine the anti-tumor activity of bevacizumab plus capecitabine based on time to disease progression•To evaluate the tolerability of bevacizumab plus capecitabine treatment in a patient population that is elderly or frail (poor performance)
Primary endpoints: •Response Evlauation Criteria in Solid Tumors (RECIST) will be used to evaluate the anti-tumor activity and disease progression of bevacizumab plus capecitabine•National Cancer Institute Common Toxicity Criteria will be used to assess the tolerability, safety and toxicity of the treatments•Progression Free Survival (PFS) will be used to assess primary endpoint for bevacizumab trials