Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Man or woman ≥ 18 years.
Competent to comprehend, sign, and date an IEC-approved (Ethics Committee) informed consent form
Histologically-confirmed metastatic adenocarcinoma of the colon or rectum by the investigator.
Wild Type K-RAS colorectal cancer determined by the designated Central Laboratory prior to inclusion in the study in the primary tumor and/or at least one metastasis.
At least 1 uni-dimensionally measurable lesion of at least > 10 mm with spiral CT per modified RECIST criteria 1.1. (Response Evaluation Criteria In Solid Tumors)

Patients with the following characteristics will be included:

Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with a disease-free interval > than 6 months after its completion.
Recurrence after adjuvant treatment with oxaliplatin +/- radiotherapy with a disease-free interval > than 12 months
De novo diagnosis of the disease.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Life expectancy ≥ 3 months
Adequate bone marrow function
Adequate Hepatic and metabolic functions
Adequate Renal function
Magnesium > LLN (Lower limit of Normal)

Exclusion Criteria:

Patients they have received prior systemic therapy for the treatment of metastatic colorectal carcinoma.
Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib) or EGFR signal transduction inhibitors.
Patients who had resection of metastatic disease
Central nervous system/brain metastases
Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
Presence of peripheral neuropathy (Common Toxicity Criteria (CTC) version 3.0 > grade 1), and of serious nonhealing wound, ulcer, or bone fracture.
Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
Treatment for systemic infection within 14 days before initiating study treatment
Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day).
Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
Any investigational agent within 30 days before enrollment
Subject who is pregnant or breast feeding
Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 14 days prior to inclusion in the study.
Woman or man of childbearing potential not consenting to use adequate contraceptive precautions