PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study
Status:
Completed
Trial end date:
2015-01-02
Target enrollment:
Participant gender:
Summary
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating
the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients
with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line
treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or
5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).
This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either
FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall
response rate in each arm at regular intervals over a maximum of 60 months follow-up.