Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
Colorectal Cancer, Metastases
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Colon, Colorectal, Rectal Cancer, Cancer, Metastatic, EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Panitumumab plus best supportive care
Best Supportive Care
Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines.
Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy.