NCT00193622已完成2 期
A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Overall response rate
研究概览
简要总结
This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.
详细描述
Upon determination of eligibility, patients will be receive:
- Bevacizumab + Erlotinib
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
- •To be included in this study, you must meet the following criteria:
- •Carcinoma of unknown primary site confirmed by biopsy
- •Measurable disease
- •ECOG performance status must be 0-1
- •Adequate bone marrow, liver and kidney
- •Understand the nature of this study and give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age< 18 years
- •May not have received EGFR inhibitors
- •History of acute myocardial infarction within 6 months
- •Clinically significant cardiovascular disease
- •Moderate to severe peripheral vascular disease.
- •History of stroke within 6 months
- •History of abdominal fistula, perforation, or abscess within 6 months
- •Active concurrent infections
- •Serious underlying medical conditions
- •Active brain metastases
- •Women who are pregnant or lactating.
- •PEG or G-tube
- •Proteinuria
- •Any nonhealing wound, ulcer, or bone fracture.
- •Any clinical evidence or history of bleeding, clotting or coagulopathy
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rate
次要结局
- Time to progression
- Overall survival
- Overall tolerability
- Overall toxicity
研究者
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