Full Text View
Tabular View
No Study Results Posted
Related Studies
Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer (ZAP)
This study is not yet open for participant recruitment.
Verified by Rochester General Hospital, November 2009
First Received: October 29, 2009   Last Updated: November 5, 2009   History of Changes
Sponsor: Rochester General Hospital
Collaborator: Novartis Pharmaceuticals
Information provided by: Rochester General Hospital
ClinicalTrials.gov Identifier: NCT01004510
  Purpose

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 Intervention Phase
Malignant Pleural Effusion
Non Small Cell Lung Cancer
Drug: zoledronic acid
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Rochester General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Zoledronic Acid: Experimental
Monthly zoledronic acid in addition to chemotherapy
Drug: zoledronic acid
Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004510

Contacts
Contact: Todd Sheppard, M.D. 585-922-4409 todd.sheppard@rochestergeneral.org
Contact: Peter Bushunow, M.D. 585-922-4020 peter.bushunow@rochestergeneral.org

Locations
United States, New York
Rochester General Hospital
Rochester, New York, United States, 14621
Sponsors and Collaborators
Rochester General Hospital
Novartis Pharmaceuticals
Investigators
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
  More Information

No publications provided

Responsible Party: Rochester General Hospital ( Todd Sheppard M.D./Principal Investigator )
Study ID Numbers: US CZOL446EUS143T
Study First Received: October 29, 2009
Last Updated: November 5, 2009
ClinicalTrials.gov Identifier: NCT01004510     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Rochester General Hospital:
malignant pleural effusion
non small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Zoledronic acid
Neoplasms by Histologic Type
Pleural Diseases
Physiological Effects of Drugs
Pleural Effusion, Malignant
Bone Density Conservation Agents
Pharmacologic Actions
Carcinoma
Pleural Effusion
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Pleural Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010