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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.
 
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
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Peter Bushunow MD, Rochester General Hospital

Tracking Information
First Submitted Date  ICMJE October 29, 2009
First Posted Date  ICMJE October 30, 2009
Results First Submitted Date  ICMJE August 14, 2012
Results First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
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 Measures  ICMJE
 (submitted: October 29, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Pleural Effusion
  • Non Small Cell Lung Cancer
Intervention  ICMJE Drug: zoledronic acid
Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
Other Name: Zometa
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 19, 2011)
3
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2009)
40
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004510
Other Study ID Numbers  ICMJE US CZOL446EUS143T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Bushunow MD, Rochester General Hospital
Study Sponsor  ICMJE Peter Bushunow MD
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
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
PRS Account Rochester General Hospital
Verification Date November 2012

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