Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer

The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior 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 (ECOG) performance status 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
• Unidimensionally measurable disease
• Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
• At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
• Adequate hematologic, renal and hepatic function

Exclusion Criteria:

• Symptomatic brain metastases requiring treatment
• History or evidence of interstitial pneumonitis or pulmonary fibrosis
• Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
• Prior epidermal growth factor receptor (EGFr) targeting therapies
• Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.