NCT00882765撤回2 期
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
研究概览
简要总结
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving genistein before surgery may be an effective treatment for pancreatic cancer.
PURPOSE: This randomized phase II trial is studying genistein to see how well it works in treating patients with pancreatic cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine changes in microvessel density of the tumor specimen after 2 weeks of treatment with genistein in patients with resectable pancreatic adenocarcinoma.
Secondary
- To evaluate the safety and tolerability of genistein in these patients by looking at the impact of genistein on pancreatic cancer angiogenesis and on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adults over the age of 18 capable of giving informed consent
- •resectable pancreatic mass, known or presumed to be primary pancreatic adenocarcinoma. Patients whose initial biopsy do not show adenocarcinoma will not receive the study drug.
- •ECOG preformance status 0-
- •Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment.
- •Exclusion criteria:
- •comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
- •hypersensitivity to genistein or to any of the excipients of genistein
- •prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
- •concomitant use of warfarin, tamoxifen, or raloxifene.
- •pregnancy or inadequate contraception.
- •lactating females
排除标准
- 未提供
结局指标
主要结局
Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
时间窗: 2 weeks
次要结局
- To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8(3 weeks)
研究者
研究点 (2)
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