A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
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 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 epidermal growth factor receptor targeting agents
- 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 with longer serum
half-life (e.g., AvastinTM) within 6 weeks before enrollment