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

INTERVENTION: 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). CONDITION: Metastatic colorectal cancer PRIMARY OUTCOME: Progression Free Survival (PFS) SECONDARY OUTCOME: Objective response rate (ORR) Overall Survival Safety of administration of each chemotherapeutic arm INCLUSION CRITERIA: 1.Histologically or cytologically documented locally advanced or metastatic colorectal cancer 2.Two‐dimensional measurable disease at least at one site, not previously irradiated (newly emerged disease at previously irradiated sites is acceptable). Ascites and pleural fluid are not considered measurable disease. 3. The diameter of one measurable lesion should be (at least one dimension)>=15 mm 4. No previous administration of chemotherapy (only neoadjuvant or adjuvant chemotherapy completed at least 4 months before patient enrollment in the protocol is acceptable). 5. Time between other anticancer treatments and patient enrollment should be:>= 4 weeks for major surgical intervention · >= 4 weeks for radiotherapy 6. Age>=18 years and performance status ECOG (Eastern Cooperative Oncology Group) 0‐2 7. Expected life span > 3 months 8. Written informed consent 9. Adequate bone marrow function: Hemoglobin >= 10 gr/dL W