NCT00147212已完成2 期
A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
研究概览
简要总结
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
详细描述
- Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle.
- Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours.
- On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered.
- On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered.
- Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects.
- Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.
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
- •Histologically confirmed adenocarcinoma of the prostate
- •Radiographically documented metastatic disease
- •Surgical or chemical castration
- •Prostate specific antigen (PSA) > 5 ng/ml
- •Castration resistant prostate cancer (CRPC)
- •One previous taxane-based chemotherapy regimen
- •Eastern Cooperative Group (ECOG) performance status 0,1 or 2
- •Neutrophil count > 1,500/ul
- •Platelet count > 100,000/ul
- •Serum bilirubin < 1.0 x upper limit normal (ULN)
- •Serum alkaline phosphatase < 1.5 x ULN
- •Asparate aminotransferase/Alanine aminotransferase < 2.5 x ULN
- •Albumin > 2.5 g/dl
- •Serum creatinine < 1.5 x ULN
- •Prior hormonal therapy
排除标准
- •Chemotherapy treatment within 4 weeks of study entry
- •Patient not employing adequate contraception
- •Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis
- •Current anti-cancer treatment with any non-FDA approved investigational drug
研究组 & 干预措施
1
Experimental
ET-743
干预措施: ET 743 (Drug)
结局指标
主要结局
The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
时间窗: Participants were followed until disease progression, an average of 6 months
Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)
次要结局
未报告次要终点
研究者
Dror Michaelson, MD
Assistant Professor of Medicine
Massachusetts General Hospital
研究点 (2)
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