Clinical trial NCT01004510: Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Non Small Cell Lung Cancer
Keywords: malignant pleural effusion
non small cell lung cancer
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2009-10-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
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
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
Study officials:
affiliation: Rochester General Hospital
name: Todd Sheppard, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rochester General Hospital
name: Peter Bushunow, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rochester General Hospital
name: Kevin Lightner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: