NCT00186420已完成2 期
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
研究概览
简要总结
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:
- •Node positive disease post-operatively
- •Capsule involvement
- •Seminal Vesicles involvement
- •Gleason score ≥ 8
- •>50% of core biopsies that are positive
- •Clinical Stage T2c and T3
- •Pre-op PSA > 15 plus Gleason score of 7
- •Age greater than 18
- •ECOG Performance Status 0-1
- •Serum creatinine <= 1.5 mg/dl
- •Granulocyte count >= 1500/m3, Hemoglobin > 8.0 g/dl, and platelet count >= 100,000/m3
- •Total bilirubin <= ULN
- •AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
- •Signed patient informed consent.
- •Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.
排除标准
- •Peripheral neuropathy > grade 1
- •History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate
- •Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
- •Active infection within 14 days of beginning treatment
- •Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
- •Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.
结局指标
主要结局
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
时间窗: Following treatment
次要结局
- To evaluate the toxicity of taxotere and hormones given adjuvantly.(Following treatment)
- To measure Quality of Life on this therapy.(Following treatment)
研究者
Sandy Srinivas
Associate Professor of Medicine
Stanford University
研究点 (2)
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