ISRCTN16465571
已完成
2 期
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2013年3月26日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Prostate cancer
- 发起方
- niversity of Birmingham (UK)
- 入组人数
- 15
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
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