A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Maximum-tolerated dose (phase I)
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ixabepilone may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when given together with radiation therapy to see how well it works in treating patients with high-risk stage III prostate cancer after surgery.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose and dose-limiting toxicity of ixabepilone in combination with concurrent intensity-modulated radiation therapy in patients with high-risk prostate cancer after prostatectomy. (Phase I)
- To determine the toxicity profile of this regimen in these patients. (Phase I)
Secondary
- To assess freedom from progression in patients treated with this regimen. (Phase II)
- To assess biochemical failure, local failure, and distant failure in patients treated with this regimen. (Phase II)
- To assess disease-specific survival and overall survival of patients treated with this regimen. (Phase II)
- To evaluate acute and late toxicity of this regimen in these patients.
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
- Male
- 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
ixabepilone
Adjuvant therapy
干预措施: ixabepilone (Drug)
ixabepilone
Adjuvant therapy
干预措施: adjuvant therapy (Procedure)
ixabepilone
Adjuvant therapy
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Maximum-tolerated dose (phase I)
时间窗: 3 years
Maximum-tolerated dose (phase I)
Dose-limiting toxicity (phase I)
时间窗: 3 years
Dose-limiting toxicity (phase I)
Freedom from progression for 3 years (phase II)
时间窗: 3 years
Freedom from progression for 3 years (phase II)
次要结局
- Time to biochemical, local and distant failure (phase II)(3 years)
- Disease-specific survival (phase II)(3 years)
- Adverse events as assessed by NCI CTCAE v. 4.0(3 years)
- Overall survival rate (phase II)(3 years)