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

Primary Purpose

Malignant Pleural Effusion, Non Small Cell Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

zoledronic acid

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring malignant pleural effusion, non small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Rochester General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic Acid

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01004510

First Posted

October 29, 2009

Last Updated

November 5, 2012

Sponsor

Peter Bushunow MD

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01004510

Brief Title

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

Acronym

ZAP

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 Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

failure to accrue projected number of patients

Study Start Date

November 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter Bushunow MD

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Effusion, Non Small Cell Lung Cancer

Keywords

malignant pleural effusion, non small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zoledronic Acid

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

zoledronic acid

Other Intervention Name(s)

Zometa

Intervention Description

Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician

Primary Outcome Measure Information:

Title

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd Sheppard, M.D.

Organizational Affiliation

Rochester General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Bushunow, M.D.

Organizational Affiliation

Rochester General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kevin Lightner, M.D.

Organizational Affiliation

Rochester General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rochester General Hospital

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

12. IPD Sharing Statement

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

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