Conditions: Colorectal Cancer Metastases
Keywords: Metastatic Colorectal Cancer, Colon Colorectal, Rectal Cancer, Cancer Metastatic, EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 463
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Best supportive care intervention 2: Panitumumab
Intervention descriptions: intervention 1: Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases). intervention 2: Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.

Protocol document: