NCT01469598已完成2 期
Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell 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
- 24
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits microtubule depolymerization.
In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8 with G-CSF support every 3 week.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
- •Age > 18 years
- •ECOG performance status 0 - 2
- •At least one measurable lesion(s) by RECIST 1.1 criteria
- •Life expectancy ≥ 3 months
- •At least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered as one regimen if administered within 6 months from the date of study entry) (upto three prior regimens will be allowed)
- •Prior radiotherapy must be completed 2 weeks before study entry.
- •Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- •Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
- •Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
- •Written informed consent
排除标准
- •Evidence of serious gastrointestinal bleeding
- •Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
- •Serious metabolic disease such as severe non-compensated diabetes mellitus
- •History of significant neurologic or psychiatric disorders
- •Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- •Pregnant or lactating woman
研究组 & 干预措施
Gemcitabine/Docetaxel
Experimental
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
干预措施: Gemcitabine/Docetaxel (Drug)
结局指标
主要结局
Response rate
时间窗: 1years
次要结局
- overall survival(1years)
- Number of Adverse Events(1years)
- progression free survival(1years)
研究者
Jeeyun Lee
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Samsung Medical Center
研究点 (1)
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