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

Information source: Rochester General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Pleural Effusion; Non Small Cell Lung Cancer

Intervention: zoledronic acid (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Peter Bushunow MD

Official(s) and/or principal investigator(s):
Todd Sheppard, M.D., Principal Investigator, Affiliation: Rochester General Hospital
Peter Bushunow, M.D., Principal Investigator, Affiliation: Rochester General Hospital
Kevin Lightner, M.D., Principal Investigator, Affiliation: Rochester General Hospital

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.

Clinical Details

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

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

Primary outcome: 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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Rochester General Hospital, Rochester, New York 14621, United States
Additional Information

Starting date: November 2009
Last updated: November 5, 2012

Page last updated: August 23, 2015

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