Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
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.
研究概览
详细说明
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.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive no specific neoadjuvant therapy. In both arms, patients undergo surgical resection in week 3.
Blood, urine, and tissue samples are collected at baseline and at the time of surgery for laboratory biomarker studies. Samples are analyzed for VEGF, CXCL1, CXCL5, and CXCL8 by ELISA and for genistein by mass spectrometry.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90095
- UCLA
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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 0-2.
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm I
Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
|
口头给予
|
|
无干预：No intervention
Patients receive no specific neoadjuvant therapy.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
大体时间：2 weeks
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2 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8
大体时间：3 weeks
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3 weeks
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合作者和调查者
调查人员
- 首席研究员：Edward Garon, MD、Jonsson Comprehensive Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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