Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
Condition: Malignant Pleural Effusion; Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion
Intervention: zoledronic acid
Intervention description: Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: malignant pleural effusion; non small cell lung cancer

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.
    

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).