NCT00458315撤回2 期
Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.
详细描述
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:
Arm A: Cisplatin, Paclitaxel and Gemcitabine
- Cisplatin 75 mg/m2 IV infusion, Day 1
- Paclitaxel 175 mg/m2 IV infusion, Day 1
- Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab)
- Cisplatin 75 mg/m2 IV infusion, Day 1
- Paclitaxel 175 mg/m2 IV infusion, Day 1
- Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
- Bevacizumab 7,5 mg/m2 IV infusion, Day 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Unknown primary tumors
- •ECOG performance status 0-1
- •Adequate kidney, liver and bone marrow function
- •No prior chemotherapy
- •Life expectancy > 3 months
排除标准
- •The following specific syndromes:
- •Squamous carcinoma limited to cervical glands
- •Women with adenocarcinoma isolated to axillary nodes
- •Women with adenocarcinoma isolated to peritoneal involvements
- •Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected
- •Neuroendocrine carcinomas
- •Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
- •Any significant cardiac disease
- •Clinically significant peripheral vascular disease
- •History of myocardial infarction or stroke within 6 months
- •Evidence of coagulopathy
- •Use of ASA, NSAIDs or clopidogrel
- •Pregnancy or breast feeding
- •Ongoing therapeutic anti-coagulation
- •Hypertension with blood pressure > 150/100 mmHg
- •Brain metastases
结局指标
主要结局
Progression Free Survival
Response
次要结局
- Response Duration
- Toxicity
研究者
Gedske Daugaard
dr.
Rigshospitalet, Denmark
研究点 (2)
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