Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 13
- 主要终点
- Overall Tumor Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine time to disease progression in patients treated with this regimen.
- Determine the 1-year survival rate in patients treated with this regimen.
- Determine the median survival time in patients treated with this regimen.
- Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Docetaxel and Cisplatin
A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
干预措施: cisplatin (Drug)
Docetaxel and Cisplatin
A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
干预措施: docetaxel (Drug)
结局指标
主要结局
Overall Tumor Response Rate
时间窗: 7 years
Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
次要结局
- 1-year Survival Rate(1 year)
- Median Survival Time(10 years)
- Time to Progressive Disease(8 years)