ACTRN12605000316606已完成2 期
A Phase II study of Paclitaxel and Vinorelbine (PaclVin) in Hormone-refractory metastatic prostate cancer: Double Tubulin Targeting. The outcome measured is PSA response.
Bristol Myers Squibb0 个研究点目标入组 30 人开始时间: 2005年9月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 ot stated（—）
- 性别
- Male
入选标准
- •Hormone-refractory prostate cancer with metastases documented by bone scan and/or CT scan, with rising PSA and/or progressive metastatic disease with serum testosterone < 3.5 nmol/L. - Patients who have not had bilateral orchidectomy should continue therapy with a Luteinizing hormone-releasing hormone analogue. Antiandrogens should be ceased at least 28 days prior to study entry. - Adequate bone marrow function: absolute neutrophil count (ANC) at least 1.5 X 109/L and platelets at least 100 X 109/L. - Adequate renal function: serum creatinine less than or equal to 200µmol/L. - Adequate liver function: bilirubin less than or equal to 20µmol/L and AST/ALT less than or equal to 5 X upper limit of normal. - ECOG performance status 0-2. - Not more than one previous line of chemotherapy (prior exposure to vinorelbine and/or taxanes not allowable).
排除标准
- •Prior radiotherapy within 21 days - Prior radioactive strontium within 42 days. - Concurrent treatment with other investigational agents.
研究者
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