Tests continuing cetuximab after first-line treatment in colorectal cancer

Who can take part

• Histologically proven diagnosis of colorectal adenocarcinoma
• Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters: Bone marrow: • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L • Hemoglobin (Hgb) ≥ 9 g/dL • Platelets ≥ 100 x 109/L Liver function: • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN Renal function: • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
• If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment
• If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate
• Signed informed consent obtained before screening
• Diagnosis of metastatic disease
• Efficacy of a first line therapy containing anti-EGFR drug with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or a prolonged (at least 6 months) stable disease
• Progression to first line therapy
• RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
• RAS (NRAS and KRAS exon 2,3 and 4), BRAFV600E, PIK3CA, EGFR ECD wild-type and HER2 not amplified in liquid biopsy at the time of screening (according to NGS, Foundation/Roche)
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1)
• Male or female patients ≥ 18 years of age
• ECOG Performance Status 0-1

Who cannot take part

• Any contraindication to the use of cetuximab, bevacizumab, Irinotecan, 5-FU, oxaliplatin, folic acid
• Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
• A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
• Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)
• History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhea
• Marked proteinuria (nephrotic syndrome)
• Known history of alcohol or drug abuse
• Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
• Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
• Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
• Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception
• Known or clinically suspected brain metastases
• Severe, non-healing wounds, ulcers or bone fractures
• Known DPD deficiency (specific screening not required)
• Absent or restricted legal capacity
• Pregnancy (exclusion to be ascertained by a beta hCG test)
• Breastfeeding
• Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study