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

November 5, 2012 updated by: Peter Bushunow MD

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14621
        • Rochester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Bushunow MD

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US CZOL446EUS143T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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