Malignant Pleural Effusion, Non Small Cell Lung Cancer
Conditions
Keywords
malignant pleural effusion, non small cell lung cancer
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.
Interventions
DRUGzoledronic acid
Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
Sponsors
Novartis Pharmaceuticals
Peter Bushunow MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid Monthly zoledronic acid in addition to chemotherapy | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Zoledronic Acid |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| control of malignant pleural effusions in non small cell lung cancer | 3 participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
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
Time frame: 3 months
Population: Too few patients enrolled to analyze data