Conditions: Colorectal Cancer
Keywords: Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study) Colorectal, Colon, Rectal Cancer, Metastatic Colorectal Cancer EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Oncology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1053
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.

Detailed description:

Arms:
arm 1: Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. arm 2: Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W arm 3: Irinotecan-based chemotherapy and Bevacizumab Q2W alone arm 4: Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Interventions: intervention 1: Oxaliplatin Based Chemotherapy intervention 2: Panitumumab intervention 3: Irinotecan Based Chemotherapy intervention 4: Bevacizumab
Intervention descriptions: intervention 1: Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 2: PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. intervention 3: Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 4: Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .

Protocol document: