NCT00564720终止2 期
Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Hellenic Oncology Research Group8 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2006年12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
- 终止
- 发起方
- 入组人数
- 140
- 试验地点
- 8
- 主要终点
- Overall Survival
研究概览
简要总结
This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed pancreatic cancer.
- •Measurable disease.
- •Absence of ascites or obstructive jaundice.
- •ECOG Performance Status 0-
- •Adequate liver kidney and bone marrow function.
- •Written informed consent.
排除标准
- •Chronic diarrheic syndrome.
- •Uncontrolled brain metastases after radiation.
- •Liver infiltration over 50%.
- •Peripheral neuropathy ≥
- •No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.
- •No active uncontrolled infection.
- •Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •Women who are pregnant or lactating.
研究组 & 干预措施
1
Experimental
GEM/TAR
干预措施: Gemcitabine (Drug)
1
Experimental
GEM/TAR
干预措施: Erlotinib (Drug)
2
Experimental
GEM/OX/TAR
干预措施: Gemcitabine (Drug)
2
Experimental
GEM/OX/TAR
干预措施: Erlotinib (Drug)
2
Experimental
GEM/OX/TAR
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1 year survival
次要结局
- Progression free interval(1 year)
- Response rate(Objective responses confirmed by CT or MRI on 3rd and 6th cycle)
- Toxicity profile(Toxicity assessment on each chemotherapy cycle)
- Symptoms improvement(Assessment every two cycles)
研究者
研究点 (8)
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