Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence
A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in treating patients who have prostate cancer that is at high risk for recurrence.
研究概览
详细说明
研究类型
阶段
- 阶段2
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
DISEASE CHARACTERISTICS: Adenocarcinoma of the prostate treated by radical prostatectomy within the past 3 months Considered to be at high risk for recurrence as defined by at least 1 of the following characteristics on the radical prostatectomy specimen: Positive seminal vesicles Gleason 6 and preoperative PSA greater than 18 ng/mL Gleason 7 and preoperative PSA greater than 14 ng/mL Gleason 8, 9, or 10 and any preoperative PSA Undetectable PSA (i.e., less than 0.1 ng/mL) within 3 months following radical prostatectomy and at time of enrollment Negative lymph nodes at time of radical prostatectomy if lymphadenectomy performed Extracapsular penetration and/or positive surgical margins allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Not specified Cardiovascular: No New York Heart Association class III or IV cardiac disease or angina pectoris No myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim or sargramostim except for febrile neutropenia Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No prior neoadjuvant or adjuvant hormonal therapy for prostate cancer No concurrent hormonal therapy except for non-disease related conditions (e.g., insulin for diabetes) No concurrent systemic corticosteriods unless for adrenal insufficiency No concurrent prednisone, dexamethasone, or other steroidal antiemetics At least 6 months since prior finasteride No concurrent finasteride No concurrent antiandrogens (e.g., flutamide, bicalutamide, nilutamide) or gonadotropin releasing hormone agonists (e.g., leuprolide, goserelin) Radiotherapy: No prior adjuvant radiotherapy for prostate cancer No prior pelvic radiotherapy for prostate cancer Surgery: See Disease Characteristics Other: At least 6 months since prior saw palmetto No concurrent compounds with 5 alpha-reductase inhibitor activity (e.g., saw palmetto)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Mitoxantrone
Patients receive mitoxantrone IV over 10-30 minutes every 21 days.
Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for the first 3 years, and then every 6 months for the next 3 years or until disease progression.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Decrease in time to failure
大体时间:Up to 3 years
|
Up to 3 years
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Decrease in the number of treatment failures
大体时间:Up to 3 years
|
Up to 3 years
|
合作者和调查者
调查人员
- 学习椅:Joseph C. Presti, MD、Stanford University
出版物和有用的链接
研究记录日期
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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