A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

Study start date: August 1, 2004

Inclusion Criteria: * Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy) * Metastatic colorectal carcinoma * Eastern Cooperative Oncology Group of 0, 1 or 2 * Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer * Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required * Bidimensionally measurable disease * Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by immunohistochemistry * At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer * Adequate hematologic, renal and hepatic function Exclusion Criteria: * Symptomatic brain metastases requiring treatment * Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis * Use of systemic chemotherapy or radiotherapy within 30 days before enrollment * Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted * Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment