NCT00494338终止2 期
A Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Efficacy of docetaxel and celecoxib by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart
研究概览
简要总结
A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed MAIPC
- •Documented progressive disease in bone, soft tissue or PSA despite castrate levels of testosterone
- •If LHRH agonist were used previously it must be kept
- •Previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
- •Previous DES should be held for at least 4 weeks before partcipating in the trial
- •Chemotherapy naive patients
- •No prior radioisotope
- •Less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
- •KPS> 70%
- •Adequate hematologic, hepatic and renal function
排除标准
- •Patients with serious medical illness
- •History of significant active cardiac disease
- •History of gastrointestinal ulceration, bleeding or perforation
- •History of myocardial infarctin within past 12 months
- •Allergy to sulfonamides or to celecoxib or history of urticaria to any NSAID
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Efficacy of docetaxel and celecoxib by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart
时间窗: two consecutive evaluations at least 4 weeks apart
次要结局
- Response in measurable disease by response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.(response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.)
研究者
研究点 (2)
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