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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

October 29, 2009
October 30, 2009
August 14, 2012
December 4, 2012
December 4, 2012
November 2009
September 2010   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01004510 on Archive Site
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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
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.
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Malignant Pleural Effusion
  • Non Small Cell Lung Cancer
Drug: zoledronic acid
Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
Other Name: Zometa
Experimental: Zoledronic Acid
Zometa administered as a 15 minute IV infusion of either 4 mg, 3.5mg, 3.3 mg or 3.0 mg every 4 weeks based on the patient's baseline calculated creatinine clearance(CrCl)using the Cockcroft-Gault formula.
Intervention: Drug: zoledronic acid
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically documented non-small cell lung cancer, Stages 3B, 4 or recurrent
  • Pleural effusion cytologically proven to be malignant
  • 0 or 1 prior chemotherapy regimens for non-small cell lung cancer (adjuvant chemotherapy post resection, or concurrent chemo-radiation therapy counts as one regimen regardless of number of agents used.)
  • Planning to start chemotherapy for non-small cell lung cancer (treatment regimen at discretion of treating physician but must include one or more of the following agents:cisplatin,carboplatin,docetaxel,paclitaxel, pemetrexed,gemcitabine,vinorelbine) Patients may receive anti-angiogenesis agents (bevacizumab) in addition to chemotherapy, but patients treated solely with tyrosine kinase inhibitors or growth-factor receptor blockers are not eligible.
  • Prior radiation therapy is permitted.
  • Performance status 0,1,2
  • Serum creatinine less than 2.0 or estimated creatinine clearance over 30cc/min by Calcroft/Gault equation
  • Estimated life expectancy over 3 months
  • Signed informed consent
  • Age greater than 18 years
  • Patients who have clinical indication for Zometa treatment such as lytic bone metastases or hypercalcemia can be included

Exclusion Criteria:

  • Pregnant or lactating
  • Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
  • Patients who undergo any procedure other than thoracentesis for drainage of effusion.Patients may have had more than one thoracentesis prior to study. Patients who have large bore chest tube placement, permanent transthoracic catheter (Pleurex), medical pleurodesis or thoracoscopy are excluded.
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular);dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks)or planned dental or jaw surgery (e.g.extraction, implants).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Peter Bushunow MD, Rochester General Hospital
Peter Bushunow MD
Novartis Pharmaceuticals
Principal Investigator: Todd Sheppard, M.D. Rochester General Hospital
Principal Investigator: Peter Bushunow, M.D. Rochester General Hospital
Principal Investigator: Kevin Lightner, M.D. Rochester General Hospital
Rochester General Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP