Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 (NSC 681239) in Previously Treated Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells
详细描述
PRIMARY OBJECTIVE:
I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC).
SECOND OBJECTIVES:
I. To compare time to progression in patients with previously treated NSCLC treated with these regimens.
II. To compare 1-year and overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
干预措施: bortezomib (Drug)
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
干预措施: docetaxel (Drug)
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
干预措施: laboratory biomarker analysis (Other)
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
干预措施: immunoenzyme technique (Other)
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
干预措施: immunohistochemistry staining method (Other)
Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
干预措施: pharmacological study (Other)
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
干预措施: docetaxel (Drug)
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
干预措施: bortezomib (Drug)
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
干预措施: laboratory biomarker analysis (Other)
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
干预措施: immunoenzyme technique (Other)
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
干预措施: immunohistochemistry staining method (Other)
Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
干预措施: pharmacological study (Other)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 4 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: 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
次要结局
- Overall Survival(From first day of treatment to time of death due to any cause, up to 4 years)
- Disease Control Rate(Up to 4 years)
- Progression-free Survival @ 6 Months(6 months)