NCT00064012已完成2 期
A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 21
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel.
Secondary
- Compare time to progression in patients treated with these regimens.
- Compare the overall and 1-year survival of patients treated with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
- Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
- Compare the quality of life 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
Velcade Alone
Active Comparator
Velcade
干预措施: bortezomib (Drug)
Velcade plus Docetaxel
Experimental
Velcade plus Docetaxel
干预措施: docetaxel (Drug)
Velcade plus Docetaxel
Experimental
Velcade plus Docetaxel
干预措施: bortezomib (Drug)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
2 期
Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00075374Case Comprehensive Cancer Center6
已完成
2 期
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast CancerBreast CancerNCT00004906Hackensack Meridian Health
已完成
2 期
Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate CancerStage IV Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate CancerNCT00020046National Institutes of Health Clinical Center (CC)
已完成
2 期
Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the ProstateProstate CancerNCT00085228European Organisation for Research and Treatment of Cancer - EORTC116
已完成
2 期
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone MetastasesMetastatic CancerProstate CancerNCT00080678M.D. Anderson Cancer Center116