NCT01004510

Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer

An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Peter Bushunow MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the addition of the bisphosphonate Zometa (zoledronic acid) used along with standard regimens of chemotherapy, will help to control the need for palliative intervention of malignant pleural effusions due to non-small cell lung cancer.

Detailed description

Malignant pleural effusions are common in late stage non-small cell lung cancer and can lead to significantly increased morbidity in this patient population. The majority of patients are symptomatic due to their malignant effusions. The recurrence rates are thought to be quite high overall and may approach 100% without any further treatment.Currently there is no available non-invasive, medical means for controlling the effusions other than systemic chemotherapy.Zoledronic acid has been shown in a mouse model of malignant pleural effusion to decrease fluid accumulation and tumor dissemination while prolonging survival.

Conditions

• Malignant Pleural Effusion
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	zoledronic acid	Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-09-01
• Completion: 2011-04-01
• First posted: 2009-10-30
• Last updated: 2012-12-04
• Results posted: 2012-12-04

Locations

1 site across 1 country: United States