ACT: Avastin and Chemotherapy followed by Avastin alone or in combination with Tarceva for the treatment of metastatic colorectal cancer

INTERVENTION: Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: bevacizumab CAS Number: 216974‐75‐3 Other descriptive name: anti‐VEGF, rhuMab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100mg/4ml‐ Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: bevacizumab CAS Number: 216974‐75‐3 Other descriptive name: anti‐VEGF, rhuMab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 400mg/16ml‐ Trade Name: Tarceva Pharmaceutical Form: Tablet INN or Proposed INN: erlotinib CAS Number: 183319‐69‐9 Other descriptive name: EGFR‐tyrosinkinaseinhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Trade Name: Tarceva Pharmaceutical Form: Tablet INN or Proposed INN: erlotinib CAS Number: 183319‐69‐9 Other descriptive name: EGFR‐tyrosinkinaseinhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Tarceva Pharmaceutical Form: Tablet INN or Proposed INN: erlotinib CAS Number: 183319‐69‐9 Other descriptive name: EGFR‐tyrosinkinaseinhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ CONDITION: Patients with previously untreated metastatic colorectal carcinoma PRIMARY OUTCOME: Main Objective: To demonstrate that maintenance treatment with bevacizumab + erlotinib (treatment A) following 1st line chemo‐ and anti‐angiogenic therapy results in a significant increase in progression‐free survival (PFS) compared to maintenance treatment with bevacizumab alone (treatment B) Primary end point(s): To demonstrate that maintenance treatment with bevacizumab + erlotinib (treatment A) following 1st line chemo‐ and anti‐angiogenic therapy results in a significant increase in progression‐free survival (PFS) compared to maintenance treatment with bevacizumab alone (treatment B) Secondary Objective: Secondary objectives: ; To evaluate the safety ; To evaluate the efficacy in terms of overall response and overall survival; Translational research for prognostic and treatment predictive markers; INCLUSION CRITERIA: Untreated metastatic colorectal carcinoma Age = 18 years Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy more than 3 months Adequate haematological, renal and liver function Blood sample and paraffin embedded tumour tissue for translational research Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range