NCT00113256终止2 期
Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 22
- 主要终点
- survival
研究概览
简要总结
Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug combination will also be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is at least 18 years of age.
- •The patient has histologically or cytologically confirmed, non-resectable, Stage II-IV primary adenocarcinoma of the pancreas.
- •The patient has had a baseline computed tomography (CT) scan, or magnetic resonance imaging (MRI), to evaluate tumor(s) within 28 days prior to randomization.
- •The patient has never been treated with prior chemotherapy, with the exception of low-dose 5-fluorouracil (5-FU) as a radiation sensitizer.
- •The patient has sufficiently recovered from the effects of previous surgery (no less than 3 weeks prior to randomization), radiotherapy, and/or immunotherapy (no less than 4 weeks prior to randomization).
- •The patient's estimated life expectancy is at least 12 weeks.
- •The patient has a Karnofsky Performance Status between 50 and
- •The patient has adequate bone marrow function.
- •The patient has adequate hepatic and renal function.
排除标准
- •The patient has any active, uncontrolled infection requiring antibiotics.
- •The patient has any serious, uncontrolled concomitant systemic disorder.
- •The patient has surgery scheduled within 8 weeks following initiation of treatment.
- •The patient is pregnant or nursing.
- •The patient is not capable of consistent oral intake of at least 3 L/day of fluid and/or requires constant intravenous (IV) hydration or frequent tube feeding.
- •The patient is receiving any investigational agent(s) or has been a participant in a clinical trial within the last 30 days.
结局指标
主要结局
survival
次要结局
未报告次要终点
研究者
研究点 (22)
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