PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

PHASE3CompletedINTERVENTIONAL
Enrollment

1,183

Participants

Timeline

Start Date

August 1, 2006

Primary Completion Date

August 1, 2009

Study Completion Date

March 22, 2013

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Panitumumab

Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

DRUG

FOLFOX regimen

The FOLFOX regimen consisted of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m\^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m\^2 IV bolus followed by 600 mg/m\^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00364013 - PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy | Biotech Hunter | Biotech Hunter