EUCTR2010-018370-21-DE进行中（未招募）不适用
Phase I/II study with Temsirolimus versus no add-on in patients with castration resistant prostate cancer (CRPC) receiving first-line Docetaxel chemotherapy CESAR Study in Prostrate Cancer with Temsirolimus added to standard Docetaxel therapy (CEPTAS) - CESAR Study in Prostrate Cancer with Temsirolimus added to standard Docetaxel therapy (CEPTAS)
CESAR Central European Society for Anticancer Drug Research EWIV0 个研究点目标入组 122 人开始时间: 2010年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Inclusion Criteria:
- •1.Adult males over 18 years of age
- •2.Performance status 0 or 1
- •3.Patients with CRPC defined as confirmed rise of PSA levels after orchiectomy or LHRH agonist therapy
- •4.Progressive disease, defined as PSA progression by confirmed rising PSA levels
- •5.PSA at time of study entry = 2 ng/ml within 1 week prior to treatment (according Scher et al. 2008)
- •6.Bone metastasis and/or lymph node and/or visceral organ metastases allowed
- •7.Neutrophils = 1.5 x 10*9/L, platelet count = 100x10*9/L, hemoglobin = 5.6 mmol/L (10 g/dL)
- •8.Total bilirubin = 2 x upper limit of normal.
- •9.AST and/or ALT = 2.5 x upper limit of normal, or = 5 x upper limit of normal in case of liver metastases
- •10.Serum creatinine = 1.5 x upper limit of normal or creatinine clearance > 60 ml/min
- •11.Written informed consent
- •12.Androgen ablation will have to be continued, antiandrogens such as bicalutamide will have to be discontinued at least 2 weeks prior to the start of study treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior Chemotherapy including estramustine (prior treatment is allowed in Phase I part)
- •2.Clinically symptomatic brain or meningeal metastasis
- •3.Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers
- •4.Any investigational drug within the 30 days before inclusion. Not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy, as judged by the investigator
- •5.Nonhealing wound or ulcer
- •6.Grade = 3 hemorrhage within the past month
- •7.Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone and temsirolimus in the discretion of the treating physician, like: Renal insufficiency requiring dialyses; congestive heart failure or uncontrolled angina pectoris; prior myocardial infarction within 6 months of start of chemotherapy; uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of = 3 anti-hypertensive drugs) or arrhythmias; instable diabetes mellitus, ulceration from diabetes mellitus or other conditions not allowing high dose corticosteroids; effusions in pericardium, pleura or abdomen symptomatic and in need of being punctured
- •8.Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate premedication (antihistamine agents)
- •9.Legal incapacity or limited legal capacity
- •10.Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
研究者
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