EUCTR2011-004090-82-GB进行中（未招募）不适用
A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neoadjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder - Bristol Bladder Trial
niversity Hospitals Bristol NHS Foundation Trust Research and Innovation Department0 个研究点目标入组 30 人开始时间: 2012年2月14日最近更新:
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
- 30
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
- All
入选标准
- •Age =18 years; Histologically confirmed primary TCC of the urinary bladder; T2 to T4 disease, N0 M0 determined by CT imaging and biopsy or transurethral resection; ECOG Performance status 0 or 1; GFR =60ml/min; Written, informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •ECOG Performance Status = 2; Lymph node involvement or metastatic disease; Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study; Active Grade =2 peripheral neuropathy; Active secondary cancers; History of severe hypersensitivity reaction (=Grade 3) to polysorbate 80 containing drugs; History of severe hypersensitivity reaction (=Grade 3) or intolerance to prednisone; Other concurrent serious illness or medical conditions; Inadequate organ function as evidenced by the following peripheral blood counts, and serum biochemistry at enrolment: Neutrophils =1.5 x 109/L, Haemoglobin =10 g/dL, Platelets =100 x 109/L, Total bilirubin > upper limit of normal (ULN), Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT)=2.5 x ULN, Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT)=2.5 x ULN, Creatinine =1.5 x ULN; Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months; Left ventricular ejection fraction =50%; Uncontrolled diabetes mellitus; Active uncontrolled gastro-oesophageal reflux disease (GORD); Active infection requiring systemic antibiotic or anti-fungal medication; Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment; Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5; Contraindications to cisplatin
研究者
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