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

NCT ID: NCT01004510

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-04-30

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.

Conditions

Malignant Pleural Effusion; Non Small Cell Lung Cancer

Keywords

malignant pleural effusion; non small cell lung cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

zoledronic acid

Intervention Type: DRUG

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

Interventions

zoledronic acid

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

Intervention Type: DRUG

Other Intervention Names

Zometa

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Peter Bushunow MD

OTHER

Sponsor Role: lead

Responsible Party

Peter Bushunow MD

Director, Oncology Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Todd Sheppard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rochester General Hospital

Peter Bushunow, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rochester General Hospital

Kevin Lightner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rochester General Hospital

Locations

Rochester General Hospital

Rochester, New York, United States

Countries

United States

Other Identifiers

US CZOL446EUS143T

Identifier Type: -

Identifier Source: org_study_id