A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 10
- 主要终点
- Overall Clinical Response Rate
研究概览
简要总结
This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.
详细描述
Upon determination of eligibility all patients will receive:
- Docetaxel + Gemcitabine + Cetuximab
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
- •To be included in the study, you must meet the following criteria:
- •18 years of age or older
- •Non-small cell lung cancer confirmed by biopsy
- •Unresectable stage III or IV disease
- •Measurable disease
- •Must not have received any prior chemotherapy for lung cancer
- •Able to perform activities of daily living without considerable assistance
- •Adequate bone marrow, kidney, and liver function
- •Signed informed consent
排除标准
- •You cannot participate in the study if any of the following apply to you:
- •History of serious heart disease within six months prior to study entry
- •Prior treatment with agents that target the EGFR pathway
- •History of any other uncontrolled or significant disease
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
研究组 & 干预措施
Intervention
Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
干预措施: Gemcitabine (Drug)
Intervention
Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
干预措施: Docetaxel (Drug)
Intervention
Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
干预措施: Cetuximab (Drug)
结局指标
主要结局
Overall Clinical Response Rate
时间窗: 18 months
Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.
次要结局
- Progression Free Survival (PFS)(18 months)
- Response Duration(18 months)