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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Peter Bushunow MD

Current Primary Outcome: Rate of Control (Lack of Need for Palliative Intervention of Malignant Pleural Effusions) in Patients With Non Small Cell Lung Cancer Treated With Standard Regimens of Cytotoxic Chemotherapy With the Addition of Zometa [ Time Frame: 3 months ]

Original Primary Outcome: Quantitate the rate of control (lack of need for palliative intervention of malignant pleural effusions) in patients with non-small cell lung cancer treated with standard regimens of cytotoxic chemotherapy with the addition of Zometa. [ Time Frame: 3 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rochester General Hospital

Dates:
Date Received: October 29, 2009
Date Started: November 2009
Date Completion:
Last Updated: November 5, 2012
Last Verified: November 2012