drugset / Trial / NCT00115765

PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study

NCT00115765

Phase 3 Completed 1053 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.

Timeline

Start
2005-06-01
Primary completion
2007-05-31
Completion
2009-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Background Bevacizumab Monoclonal antibody Intravenous
Background Irinotecan Small molecule
Background Leucovorin Small molecule
Background Oxaliplatin Small molecule
Background fluorouracil Small molecule

Indications