Randomized phase III trial of irinotecan in combination with capecitabine or fluorouracil (5-FU)/leucovorin (LV) and bevacizumab as first-line treatment in patients with metastatic colorectal cancer

Interventions: Bevacizumab (AVASTIN): 7.5 mg/kg of body weight, 90min intravenous (i.v.) infusion day 1 (AVASTIN should not be mixed into Dextrose solutions)
followed by
Irinotecan (CPT-11): 240mg/m2 intravenous (i.v.), 90 minutes infusion day 1
followed by
Capecitabine (XELODA):1000 mg/m2 per os (it is administered orally within 30 minutes after the end of breakfast or dinner) twice daily days 1-14
The regimen will be repeated every 3 weeks for a total of 6 cycles. Treatment should be continued for 6 cycles and be interrupted in case of progression of disease during treatment or non-acceptable toxicity or consent withdrawal. After the end of treatment, patients are followed every 3 months until death or until the date of interruption (date of disease progression or initiation of other antineoplastic treatment).
Primary outcome(s): Progression Free Survival (PFS)[8 months from study initiation. This outcome is assessed by laboratory evaluation of hematology and biochemistry (including tumor markers), computed tomography (CT) scan or other imaging studies as indicated.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial