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

Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer

The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line 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 epidermal growth factor receptor (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