PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study

PHASE3CompletedINTERVENTIONAL
Enrollment

1,053

Participants

Timeline

Start Date

June 1, 2005

Primary Completion Date

May 31, 2007

Study Completion Date

May 1, 2009

Conditions
Colorectal Cancer
Interventions
DRUG

Oxaliplatin Based Chemotherapy

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.

DRUG

Panitumumab

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.

DRUG

Irinotecan Based Chemotherapy

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.

DRUG

Bevacizumab

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 .

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00115765 - PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study | Biotech Hunter | Biotech Hunter