De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer

Exclusion Criteria

• •Patient with a potentially resectable colorectal cancer; i.e. for whom the goal of chemotherapy would be to make all metastases resectable
• •Patients with symptomatic metastases
• •Patient with aggressive disease and a large tumour volume
• •Active gastroduodenal ulcer, wound or bone fracture
• •At least one of the following laboratory values: Neutrophils \<1500/mm3, platelets \< 100,000/mm3, haemoglobin \< 9 g/dL, total bilirubin \> 1.5 N, alkaline phosphatase \> 2.5 N (or \> 5 N in case of hepatic involvement), serum creatinine \> 1.5 N, 24 hr proteinuria \> 1 g
• •Chronic inflammatory bowel disease, extensive resection of the small bowel
• •Clinically significant coronary artery disease or a history of myocardial infraction within the last 6 months. Uncontrolled hypertension while receiving chronic medication
• •Abdominal or major extra-abdominal surgical procedure (except diagnostic biopsy) or radiation within 4 weeks before starting treatment
• •Previous treatment with an anti-angiogenic or irinotecan
• •Known or suspected central nervous system metastasis CNS metastases, or suspected CNS metastases
• •Other previous malignancies within 5 years, except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix - Peritoneal macro-nodular carcinomatosis
• •History of haemoptysis ≥ grade 2 (defined as ≥ 2.5 mL of bright red blood per episode) in the month prior to inclusion
• •Known hypersensitivity to any component of bevacizumab or to one of the study treatments
• •Active infection requiring intravenous antibiotics at start of treatment
• •History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to treatment start
• •Pregnant or breastfeeding women
• •Concomitant participation in another clinical study involving a drug during the treatment phase and 30 days before starting the study treatment
• •Patient unable to undergo medical treatment for geographical, social, psychological or legal reasons.