A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment.
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
- •Advanced cancer not eligible for curative treatment.
- •A measurable lesion in the thorax, abdomen or pelvis.
- •Normal organ and bone marrow function.
- •Able to receive protocol prescribed radiation. Please refer to the protocol for detailed inclusion criteria.
排除标准
- •Overlap of treatment field with a previous radiation field.
- •Inability to meet mandated normal tissue radiation dose constraints.
- •Brain metastases (unless previously treated and controlled)
- •Previous treatment with Sorafenib.
- •Poorly controlled Hypertension.
- •Unable to swallow sorafenib tablets.
- •Intercurrent cardiac dysfunction.
- •Uncontrolled intercurrent illness. Please refer to the protocol for detailed exclusion criteria.
研究组 & 干预措施
Sorafenib and Radiation
Eligible patients (not candidates for curative treatment) will have measurable lesions in the anatomic thorax, abdomen or pelvis (any histology) amenable to palliative radiation treatment (30 Gy in 10 fractions). Patients receive sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. If full oral dose (400 mg po bid) is reached in a given cohort (dose level three) then an additional dose level will open where sorafenib treatment (400 mg bid) is extended following radiation for a total of eight weeks.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Outcome is measured prior to each dose escalation.
To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.
次要结局
- Sorafenib with radiation treatment efficacy(12 weeks from initiation of study treatment.)