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An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Malignant Pleural Effusion, Non Small Cell Lung Cancer

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Trial Information

An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer

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.

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
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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Todd Sheppard, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rochester General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

November 2009

Completion Date:

April 2011

Related Keywords:

  • Malignant Pleural Effusion
  • Non Small Cell Lung Cancer
  • malignant pleural effusion
  • non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant



Rochester General HospitalRochester, New York  14621