Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Metastatic Cancer, Vectibix, Abgenix, Amgen
Eligibility Criteria
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 is required Bidimensionally measurable disease Tumor expressing 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 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Panitumumab
Participants received panitumumab 6 mg/kg once every 2 weeks weeks administered by intravenous (IV) infusion until progressive disease, inability to tolerate the investigational product, or discontinuation of treatment for other reasons.