A Phase II Study of Sorafenib in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Prostate Specific Antigen (PSA) Response Rate
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving sorafenib together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel.
Secondary
- To estimate the progression-free survival of patients with AIPC.
- To quantify the number and percent of patients who have stable disease at 6 months of therapy (failure to progress).
- To estimate median time to progression for all patients.
- To estimate the objective response rate of patients with AIPC treated with this regimen.
- To measure the percentage of patients surviving at 2 years.
- To determine the toxicities and estimate toxicity rates for patients treated with this regimen.
- To measure changes in tumor vasculature in response to therapy in selected patients with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives to these measurement changes.
- To measure changes in serum HMGB1 in response to therapy and correlate primary and secondary objectives with these changes.
- To measure changes in serum cathepsin D in response to therapy and correlate primary and secondary objectives with these changes.
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
Phase II
All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks
干预措施: docetaxel (Drug)
Phase II
All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Prostate Specific Antigen (PSA) Response Rate
时间窗: From start of treatment until withdrawal from the study, approximately 12 months
PSA Response: ≥50% decline from baseline PSA measurement confirmed by a second PSA measurement 3 weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression. PSA progression (PSA-P): Two measurements of rising serum PSA measured at least 2 weeks apart where the second is greater than the first.
次要结局
- Objective Response Rate (ORR)(6 months from end of treatment)
- 6-month Progression-free Survival (PFS)(6 months from end of treatment)