NCT00329589已完成1 期
A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients
Sidney Kimmel Cancer Center at Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2005年9月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy
研究概览
简要总结
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.
详细描述
- To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
- To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
- To evaluate tumor response
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 malignancy
- •Requiring at least grade 2 weeks of radiation therapy
- •Solid tumors of the central nervous system, head and neck area, and cervix
- •World Health Organization (WHO) performance status equal to or less than 2
排除标准
- •Equal to or greater than grade 2 peripheral neuropathy
- •Myocardial infarction within 6 months
- •Hypersensitivity to bortezomib, boron, or mannitol
研究组 & 干预措施
CNS
Experimental
Velcade (bortezomib)
干预措施: Velcade (bortezomib) (Drug)
Head and Neck
Experimental
Velcade (bortezomib)
干预措施: Velcade (bortezomib) (Drug)
Cervix
Experimental
Velcade (bortezomib)
干预措施: Velcade (bortezomib) (Drug)
结局指标
主要结局
To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy
时间窗: 2-8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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