A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy
This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy.
Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor.
All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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New Jersey
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Bridgewater、New Jersey、美国、08807
- Sanofi-Aventis US
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
INCLUSION CRITERIA:
- patients with prostate cancer who have just undergone prostatectomy,
- high risk of their cancer recurring (High risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.)
EXCLUSION CRITERIA:
- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
- Prior radiation therapy
- Patients receiving any concurrent therapy for cancer. This includes alternative therapies
- Patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids.
- History of a malignancy other than prostate cancer
- Peripheral neuropathy >/= Grade 2
- Psychological, familial, sociological or geographical conditions which do not permit treatment and/or medical follow-up required to comply with the study protocol
- Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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To assess the preliminary effects of six cycles of adjuvant, weekly Taxotere® (three weeks on/one week off) on the rate of progression-free survival
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合作者和调查者
赞助
调查人员
- 研究主任:Yasir Nagarwala, M.D.、Sanofi
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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