The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle: * Oxaliplatin 85mg/m2 as a 120 minute infusion on day 1 of each cycle * Folinic acid 200mg/m2 as a 120 minute infusion on days 1 and 2 * A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on days 1 and 2 * 5-FU at 600mg/m2 as a continuous infusion of 22 hour infusion on days 1 and 2
Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle: * Irinotecan 180 mg/m2 will be administered over 90 minutes ± 15 minutes on day 1 of each cycle * Folinic acid 400 mg/m2 will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing * A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on day 1 * 5-FU at 2400 mg/m2 continuous intravenous infusion over 46-hour ± 2-hour on day 1 of each cycle.
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain
Objective response rate
Time frame: 2009-2013
% of patients whose disease becomes resectable
Time frame: 2009-2013
Time to resection
Time frame: 2009-2013
Duration of response
Time frame: 2009-2013
Progression-free survival
Time frame: 2009-2013
Time to treatment failure
Time frame: 2009-2013
Time to disease relapse following surgery.
Time frame: 2009-2013
Adverse Events
Time frame: 2009-2013
Evaluation of molecular predictive markers for response.
Time frame: 2009-2013
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