Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With mCRC

Inclusion Criteria:

* Man or woman \> 18 years of age
* Competent to comprehend, sign, and date an IEC-approved informed consent form
* Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or rectum.
* Radiographically documented disease progression per modified RECIST criteria either while receiving or ≤ 6 months after the last dose of prior first-line chemotherapy for mCRC
* At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria.
* If subject has prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or active disease within 5 years.
* Prior radiotherapy is acceptable.
* One and only one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy.
* ECOG performance status of 0, 1 or 2
* Life expectancy ≥ 3 months
* Hematologic function:ANC \> 1.5 x 109/L, Platelet count \> 100 x 109/L, Hemoglobin \> 10 g/dL
* Renal function: Creatinine \< 1.5 mg/dL
* Hepatic function: AST and ALT \< 3 x ULN (if liver metastases \< 5 x ULN)
* Bilirubin \< 2 x ULN

Exclusion Criteria:

* No more than one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based chemotherapy is allowed)
* Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months prior to enrolment.
* Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
* Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
* Central nervous system/brain metastases
* Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
* Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib)
* 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
* Radiotherapy ≤ 14 days prior to inclusion. Patients must have recovered from all radiotherapy-related toxicities
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as \> 4 loose stools per day)
* History of Gilbert's syndrome or dihydropyrimidine deficiency
* History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results
* Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
* subject allergic to the ingredients of the study medication or to Staphylococcus protein A
* Any co-morbid disease that would increase risk of toxicity
* Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
* Any investigational agent within 30 days before enrolment
* Must not have had a major surgical procedure within 28 days of randomization
* Subject who is pregnant or breast feeding
* Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods
* Subject unwilling or unable to comply with study requirements