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

NCT01004510 | Terminated Phase 2 Results

• 1 other identifier: US CZOL446EUS143T
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion; Non Small Cell Lung Cancer

Keywords

malignant pleural effusion; non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (1)

Zoledronic Acid

EXPERIMENTAL

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

Interventions

zoledronic acid DRUG

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

Also known as: Zometa

Zoledronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented non-small cell lung cancer, Stages 3B, 4 or recurrent
• Pleural effusion cytologically proven to be malignant
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peter Bushunow MD: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Rochester General Hospital

Rochester, New York, 14621, United States

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Todd Sheppard, MD
• Organization: Rochester General Hospital

todd.sheppard@rochestergeneral.org

585-922-4409

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Oncology Research

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: April 1, 2011
• Last Updated: December 4, 2012
• Results First Posted: December 4, 2012

Record last verified: 2012-11

Locations

US (1)