Zalutumumab with or without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer

Primary ObjectivePart 1 • Evaluate the safety of escalating dose of zalutumumab in combination with irinotecan in patients with colorectal cancer (CRC) who have failed previous standard chemotherapy and who have progressed during or within 6 months of stopping treatment with cetuximab.Part 2• To investigate the efficacy of zalutumumab administered alone or in combination with irinotecan in patients with CRC who have failed previous standard chemotherapy and who have progressed during or within 6 months of stopping treatment with cetuximab.
Primary endpoints: Part 1• Adverse events, clinical laboratory tests and vital signsPart 2• Objective Response Rate, defined as complete or partial response according to best overall response (verified by imaging technique and according to RECIST criteria).