Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Colorectal Cancer
Interventions
DRUG

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"

DRUG

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."

Trial Locations (1)

28046

Spanish Cooperative Group for Gastrointestinal Tumour Therapy, Madrid

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER