80
Participants
Start Date
May 31, 2009
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
Panitumumab+FOLFOX-4
"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+FOLFIRI
"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
Collaborators (1)
Amgen
INDUSTRY
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
OTHER