NCT00393497

A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer.

Detailed description

The primary objective of this study is: • To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema The secondary objectives of this study are: * To assess the degree of improvement in arm edema as measured by changes in arm interstitial fluid pressure (IFP) * To assess the degree of improvement in arm edema as measured by changes in extracellular fluid (ECF) volume based on bioelectrical impedance analysis (BIA) by lymphometer * To assess the safety and tolerability of VEGF inhibition in this patient population * To assess the clinical benefit in patients with ipsilateral lymphedema treated with vascular endothelial growth factor (VEGF) inhibition by evaluating patient responses to a quality of life questionnaire (FACT-B+4 lymphedema questions) * To determine the impact of VEGF inhibition on circulating VEGF levels in patients with lymphedema

Conditions

• Breast Cancer
• Lymphedema

Interventions

Type	Name	Description
DRUG	bevacizumab	Bevacizumab 15 mg/kg IV every 21 days

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-10-01
• Completion: 2011-01-01
• First posted: 2006-10-27
• Last updated: 2014-09-22

Locations

1 site across 1 country: United States