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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

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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Non Small Cell Lung Cancer Drug: zoledronic acid Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Drug: zoledronic acid
Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
Other Name: Zometa

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01004510

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United States, New York
Rochester General Hospital
Rochester, New York, United States, 14621
Sponsors and Collaborators
Peter Bushunow MD
Novartis Pharmaceuticals
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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

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Responsible Party: Peter Bushunow MD, Director, Oncology Research, Rochester General Hospital Identifier: NCT01004510    
Other Study ID Numbers: US CZOL446EUS143T
First Posted: October 30, 2009    Key Record Dates
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012
Last Verified: November 2012
Keywords provided by Peter Bushunow MD, Rochester General Hospital:
malignant pleural effusion
non small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion, Malignant
Pleural Effusion
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Pleural Neoplasms
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs