Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Complete Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.
详细描述
OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.
OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.
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
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •No prior hormones, radiation or chemotherapy for prostate cancer
- •Evidence of serious active infection
研究组 & 干预措施
Docetaxel
Docetaxel given via iv at determined dose once a week for 4 weeks
干预措施: docetaxel (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 2 Months, 6 Months
Wilcoxon Signed Rank Test
次要结局
- Percentage of Participants with mild to moderate toxicity(6 months)
研究者
Mary-Ellen Taplin, MD
Taplin, Mary-Ellen
Dana-Farber Cancer Institute