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

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ClinicalTrials.gov Identifier: NCT01004510
Recruitment Status : Terminated (failure to accrue projected number of patients)
First Posted : October 30, 2009
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Peter Bushunow MD, Rochester General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Malignant Pleural Effusion
Non Small Cell Lung Cancer
Intervention: Drug: zoledronic acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Zoledronic Acid Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.

Participant Flow:   Overall Study
    Zoledronic Acid
Adverse Event                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Zoledronic Acid Monthly zoledronic acid in addition to chemotherapy

Baseline Measures
   Zoledronic Acid 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   2 
[Units: Participants]
Female   2 
Male   1 
Region of Enrollment 
[Units: Participants]
United States   3 
control of malignant pleural effusions in non small cell lung cancer 
[Units: Participants]

  Outcome Measures

1.  Primary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Todd Sheppard, MD
Organization: Rochester General Hospital
phone: 585-922-4409
e-mail: todd.sheppard@rochestergeneral.org

Responsible Party: Peter Bushunow MD, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT01004510     History of Changes
Other Study ID Numbers: US CZOL446EUS143T
First Submitted: October 29, 2009
First Posted: October 30, 2009
Results First Submitted: August 14, 2012
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012