NCT00578149已完成2 期
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
研究概览
简要总结
This study is being done to learn what effects (good and bad) bevacizumab in conjunction with carboplatin/paclitaxel and radiation therapy has on patients with non-small cell lung cancer (NSCLC).
详细描述
- There are three phases of treatment 1)chemoradiation, 2) consolidation and 3)maintenance therapy.
- The chemoradiation phase is from week 1 to week 7. The following will occur during this phase: Daily chest radiation starting on day 1; pre-medication for paclitaxel; weekly intravenous administration of paclitaxel and carboplatin; intravenous administration of bevacizumab once weekly every three weeks starting on day 1.
- During weeks 8-9, patients will undergo a PET/CT scan for restaging.
- The consolidation phase is from week 10 to week 16. The following will occur during this phase: Pre-medication for paclitaxel; intravenous administration of paclitaxel and carboplatin twice weekly every 3 weeks; intravenous administration of bevacizumab once weekly every 3 weeks.
- The maintenance phase is from week 17 to week 52. The following will occur during this phase; intravenous administration of bevacizumab once a week every three weeks for 1 year; PET/CT scan every three months.
- The following evaluations will occur during treatment: 1)Patients will be evaluated weekly by the study doctor, 2) Weight, difficulty or discomfort in swallowing, shortness of breath and over well-being will be recorded, 3) Weekly lab test will include CBC, chemistries, and liver function tests. 4) Followed through each cycle of chemotherapy and every 6-8 weeks for the duration of the study.
- The following evaluations will occur after treatment: 1)Every 6-8 weeks assessed for response with a CT or PET/CT scan for one year, 2) Toxicity will also be assessed at each follow-up interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 confirmed non-small cell lung cancer (NSCLC) that have been evaluated and determined not to be candidates for surgical resection as part of their definitive management of stage III disease.
- •Age 18 years or older
- •ECOG performance status of 0-1
- •Life Expectancy of greater than six months
- •Normal organ and marrow function
- •Women and men of child-bearing potential must agree to use adequate contraception
排除标准
- •Prior chemotherapy or thoracic radiation therapy
- •Squamous histology or any histology in close proximity to a major vessel
- •Active hemoptysis
- •History of hypercoagulability
- •Known distant metastatic disease
- •History of allergic reactions attributed to compounds with similar chemical or biological composition to bevacizumab, carboplatin, paclitaxel or other agents used in this study
- •Patients with uncontrolled intercurrent illness
- •Pregnant women
- •Major surgical procedure, open biopsy, or significant traumatic injury with in 28 days prior to day 0
- •Minor surgical procedure within 7 days to day 0
- •HIV-positive patients receiving combination anti-retroviral therapy.
- •Non-skin cancer malignancy in the past 5 years.
结局指标
主要结局
To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
次要结局
- Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.
研究者
研究点 (4)
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