Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

Inclusion Criteria:

• Diagnosis of metastatic adenocarcinoma of the colon or rectum
• Available paraffin-embedded tumor tissue
• Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
• Measurable disease
• Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

• Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
• Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
• Prior irinotecan therapy. anti EGFr therapy, or vaccine for the treatment of mCRC
• CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
• Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
• Clinically significant cardiovascular disease
• History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
• Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
• Any significant bleeding ≤6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
• Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
• Any co morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
• Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications