NCT00268840已完成2 期
National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery
ARCAGY/ GINECO GROUP1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2001年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.
详细描述
Try a new drug association on this advanced cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Patients must sign informed consent prior to study entry
- •Patients has Karnofsky performance status of more than 50%
- •No prior chemotherapy
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
- •No previous radiotherapy for locally advanced or metastases.
- •Hematopoietic: WBC > 3000/mm2, Absolute neutrophile count > 1500/mm2, Hemoglobin > 9g/dl, Platelet count > 100 000/mm2
排除标准
- •No intracerebral or meningeal metastases
- •Fertile patient must use effective contraception
- •No other serious medical condition or illness that would preclude study participation
- •Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT > 3.5 times upper limit of normal(ULN) alkaline phosphatase > 6 times upper limit of normal(ULN)
- •More than 30 days since prior investigational therapy
研究组 & 干预措施
unique
Experimental
Taxotère - Gemzar
干预措施: Docetaxel (Drug)
unique
Experimental
Taxotère - Gemzar
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall response rate
次要结局
- Overall survival
- Progression-free survival
- Clinical benefit
- To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel
研究者
研究点 (1)
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