Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
2017年4月9日 更新者:University of Southern California
Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer
Prostate cancer is a common and important health issue.
Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable.
The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth.
Although this treatment is successful for many patients, the cancer may eventually return in others.
Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease.
Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).
研究概览
详细说明
Patients will undergo a screening procedure to determine eligibility of trial.
During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle.
Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study.
The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits.
These visits take place whenever the research medication is stopped, even if it is stopped early.
For the patient's safety, he/she should at least complete the end of treatment visit.
研究类型
介入性
注册 (实际的)
27
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Beverly Hills、California、美国、90211
- Westside Prostate Cancer Center, University of Southern California
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Los Angeles、California、美国、90033
- USC/Norris Comprehensive Cancer Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Age ≥ 18 years.
- Signed informed consent
- ECOG performance status: 0-2
- Histologically documented adenocarcinoma of the prostate
- Progressive disease despite androgen deprivation therapy. Progressive disease is defined as any one of the following:
- Measurable Disease: Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of one or more new lesions (Modified RECIST Criteria)
- Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer
- PSA Progression: An elevated PSA (≥ 5 ng/ml) which has risen serially from baseline on two occasions each at least one week apart
- At least 4 weeks since any other hormonal therapy. Flutamide and megestrol acetate (any dose) must be discontinued at least 4 weeks prior to initiating treatment. Bicalutamide or nilutamide must be discontinued at least 6 weeks prior to initiating treatment. If improvement following antiandrogen withdrawal is noted, progression must be established using the criteria above. Androgen suppression should be continued
- ≥ 4 weeks since major surgery and fully recovered
- ≥ 8 weeks since high risk surgery and fully recovered
- ≥ 4 weeks since any prior radiation and fully recovered
- ≥ 6 weeks since the last dose of bone targeted radiopharmaceutical
- Men of child-bearing potential are required to use an effective means of contraception
Required Initial Laboratory Values:
- ANC ≥ 1500/µL
- Platelet count ≥ 100,000/µL
- Creatinine ≤ 1.5 x ULN
- Bilirubin ≤ 1.5 x ULN
- AST ≤ 1.5 x ULN
- Urine protein to creatinine ratio < 1.0
- Serum Testosterone ≤ 50 ng/dL (For patients who have not had bilateral orchiectomy.)
Exclusion Criteria:
- Prior treatment with cytotoxic chemotherapy for metastatic disease
- Prior treatment with anti-angiogenic agents, including thalidomide and bevacizumab
- Prior treatment with any investigational drug within 4 weeks of initiating treatment
- Prior treatment with an mTor inhibitor
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Known history of HIV seropositivity
- Known brain metastases (brain imaging is not required)
- Congestive heart failure
- Uncontrolled hypertension. Patients with history of hypertension must be well controlled (< 150/100) on a regimen of anti-hypertensive therapy
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Active bleeding diathesis or on oral anti-vitamin K medications (except low dose coumarin)
- Arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), at any time
- History of unstable angina or angina requiring surgical or medical intervention in the past 12 months, or myocardial infarction (MI)
- Patients with clinically significant peripheral artery disease or any other arterial thrombotic event
- Significant vascular disease
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Proteinuria at screening as demonstrated by either
- Urine protein:creatinine (UPC) ratio ≥ 1.0 OR
- Urine dipstick for proteinuria ≥ 2+
- Serious or non-healing wound, ulcer or bone fracture
- Peripheral neuropathy ≥ grade 2
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Herbal medications and food supplements must be discontinued before registration. Patients may continue on daily vitamins and calcium supplements
- History of noncompliance to medical regimens
- Unwilling to or unable to comply with the protocol
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:1个
|
RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m^2 every 21 days
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
大体时间:After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
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After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer.
大体时间:overall survival
|
overall survival
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Mitchell E Gross, MD, Ph.D、University of Southern California
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年2月17日
初级完成 (实际的)
2016年2月17日
研究完成 (实际的)
2017年2月17日
研究注册日期
首次提交
2007年12月14日
首先提交符合 QC 标准的
2007年12月14日
首次发布 (估计)
2007年12月17日
研究记录更新
最后更新发布 (实际的)
2017年4月11日
上次提交的符合 QC 标准的更新
2017年4月9日
最后验证
2017年4月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 4P-09-4
- AVF3955s
- CRAD001CUS2468
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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