NCT00531687终止2 期
Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Primary objective · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. · ·
研究概览
简要总结
Study Objectives:
Primary objective
- The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.
Secondary Objectives
- Overall survival
- Progression free survival
- Response rates (RECIST)
- Duration of response
- To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
详细描述
not relevant
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG);
- •Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR)
- •Age greater than or equal to 18 years;
- •Performance status 0,1,2 or 3
- •WBC > 3000 mill/l, ANC > 1500 mill/l, platelet count > 100.000 mill/l; serum bilirubin < 1.5 x the upper limit of normal;
- •Adequate renal function (Glomerular Filtration Rate (GFR) >60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance)
- •signed informed consent;
排除标准
- •Uncontrolled active severe clinical infection (CTC grade 3 or 4).
- •Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders.
- •Grade 2 or greater peripheral neuropathy according to the CTC, version 3.
- •Second malignancy other than basal or squamous cell skin cancer.
研究组 & 干预措施
GCT
Other
cisplatin Paclitaxel gemcitabine
干预措施: Paclitaxel (Drug)
GCT
Other
cisplatin Paclitaxel gemcitabine
干预措施: Cisplatin (Drug)
GCT
Other
cisplatin Paclitaxel gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Primary objective · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. · ·
时间窗: December 2010
次要结局
- Secondary Objectives · Overall survival(5 years)
- Secondary Objectives · Progression free survival(5 years)
- Secondary Objectives · Response rates (RECIST)(5 years)
- Secondary Objectives · Duration of response(5 years)
- Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP(5 years)
研究者
Gedske Daugaard
Associate professor
Rigshospitalet, Denmark
研究点 (1)
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