NCT00911170

PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 847 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Colon Cancer
• Colorectal Cancer
• Fever
• Locally Advanced
• Metastatic Colorectal Cancer
• Neutropenia
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Pegfilgrastim	Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product.
DRUG	Placebo	Administered as a single subcutaneous injection using a pre-filled syringe.
BIOLOGICAL	Bevacizumab	5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle.
DRUG	Standard Chemotherapy	Each participant received one of the following chemotherapy regimens at the discretion of treating physician: FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil.

Timeline

• Start date: 2009-11-03
• Primary completion: 2012-09-17
• Completion: 2015-01-02
• First posted: 2009-06-01
• Last updated: 2017-12-29
• Results posted: 2014-01-07

Locations

154 sites across 17 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, France, Hungary, Ireland, Italy, Latvia, Mexico, Poland, Romania, Russia, Slovakia, Ukraine