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

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 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

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 ]

Enrollment:	3
Study Start Date:	November 2009
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zoledronic Acid 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 Other Name: Zometa

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

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:	Todd Sheppard M.D./Principal Investigator, Rochester General Hospital
ClinicalTrials.gov Identifier:	NCT01004510 History of Changes
Other Study ID Numbers:	US CZOL446EUS143T
Study First Received:	October 29, 2009
Last Updated:	July 26, 2011
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:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012