A multicentre, phase II randomised controlled trial evaluating cabazitaxel versus docetaxel rechallenge for the treatment of metastatic castrate refractory prostate cancer, previously treated with docetaxel at inception of primary hormone therapy

niversity of Birmingham (UK)0 个研究点目标入组 15 人开始时间: 2013年3月26日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•1. Diagnosis of histologically proven prostate adenocarcinoma, that is castrate refractory
•2. Previously treated with up to 6 cycles of Docetaxel at the same time (defined as commencing within 3 months) as instigation of primary hormone therapy.
•3. Confirmed biochemical, radiological or clinical progression.
•4. Metastatic disease
•5. Male and female, aged 18 or over
•6. WHO performance status grade 0 to 2
•7. Adequate organ function as evidenced by:
•7.1. ANC >1.5 x109/L
•7.2. WBC >3.0 x109/L
•7.3. Haemoglobin >10g/dL
•7.4. Platelet count > 100 x10^9L
•7.5. Total bilirubin <1.0 xULN
•7.6. AST/ ALT <1.5 xULN
•7.7. GFR >30ml/min (calculated by EDTA clearance, 24h urine collection, or Cockcroft-Gault)
•8. Available for long-term follow up
•9. Patient?s written informed consent

•1. Prior systemic therapy with other chemotherapy drugs
•2. Metastatic brain disease or leptomeningeal disease
•3. Patients with bilirubin equal to or greater than 1.0 xULN
•4. Previous extensive palliative radiotherapy to bone marrow, e.g. hemibody radiotherapy
•5. Active grade >=2 peripheral neuropathy (NCI CTC v 4)
•6. Active infection requiring systemic antibiotic or antifungal medication
•7. Patients with reproductive potential not implementing accepted and effective method of contraception

发起方

niversity of Birmingham (UK)