Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favorable FcγRIIa (CD32) Genotype

Inclusion Criteria

• Written informed consent form signed by the subject
• Age greater than or equal to (>=) 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (= ) 2 months
• Histological confirmed colorectal cancer (CRC) with mutated K-RAS and favorable genotypes (any H in FcγRIIa-131). Selection will be done only based on Cluster of differentiation (CD)32 polymorphisms
• Epidermal growth factor receptor (EGFR) expression in his/her tumor sample
• Stage 4 metastatic disease, with at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, documented within 28 days prior to the study inclusion
• Tumor tissue sample available for the assessment of K-RAS status and FcγRIIa (CD32) genotype
• Subject who has received at least 2 prior therapeutic lines
• Adequate bone marrow function, defined as:
• haemoglobin > 9.0 gram per deciliter (g/dL)
• platelet count >100*10^9 per liter
• absolute neutrophil count (ANC) >=1.5*10^9/Liter
• Adequate hepatic and renal function, defined as:
• Serum bilirubin = = 50 milliliter per minute (mL/min) (according to Cockcroft and Gault formula) or serum creatinine =2 congestive cardiac insufficiency according to New York Heart Association (NYHA) within 6 months before starting the study treatment
• Clinically significant vascular disease (for example, aortic aneurysm which requires surgery, pulmonary embolism, recent peripheral arterial thrombosis) within 12 months prior to starting the study treatment
• Evidence of uncontrolled brain metastases
• History of active neurological disease
• History of uncontrolled seizures
• History of lung fibrosis, acute pulmonary damage or interstitial pneumonia
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C infection, or presence of severe, uncontrolled intercurrent infections or other severe uncontrolled concomitant diseases
• Current Grade >=2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]) infection
• History of uncontrolled diabetes, uncontrolled hypertension or hepatic involvement
• Known or suspected allergy or hypersensitivity to cetuximab
• History of previous malignancy other than CRC occurring within 5 years before starting the study treatment, except for previously cured basal cell carcinoma of skin or carcinoma in situ of the cervix or urinary bladder treated more than 2 years before recruitment
• Participation in another treatment study with an investigational drug within the last 30 days
• Pregnancy or lactation
• Any medical, psychological, psychiatric or social uncontrolled problem which may interfere in the participation of the subject in the study or in the evaluation of the study results
• Psychological, familiar or geographic conditions not allowing the adequate follow-up and adherence to the study protocol