An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Zoledronic Acid
Zometa administered as a 15 minute IV infusion of either 4 mg, 3.5mg, 3.3 mg or 3.0 mg every 4 weeks based on the patient's baseline calculated creatinine clearance(CrCl)using the Cockcroft-Gault formula.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
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
时间窗: 3 months
次要结局
未报告次要终点
研究者
Peter Bushunow MD
Director, Oncology Research
Rochester General Hospital