Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer
Colorectal Cancer, Metastases
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colon, Rectal Cancer, ABX-EGF, Panitumumab, EGFr, Immunex, Abgenix, Amgen, Metastatic Colorectal Cancer, Vectibix
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Panitumumab
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.