NCT00882765撤回2 期
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 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.
排除标准
- •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
研究组 & 干预措施
No intervention
No Intervention
Patients receive no specific neoadjuvant therapy.
Arm I
Experimental
Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: genistein (Dietary Supplement)
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 (1)
Loading locations...
相似试验
已完成
1 期
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney CancerMelanoma (Skin)Kidney CancerNCT00276835Northwestern University15
终止
2 期
Genistein in Treating Patients With Prostate CancerAdenocarcinoma of the ProstateStage II Prostate CancerStage III Prostate CancerRecurrent Prostate CancerStage I Prostate CancerNCT01126879Northwestern University12
终止
2 期
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical ProstatectomyProstate CancerNCT00058266Northwestern University36
Unknown
2 期
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung CancerLung CancerNCT00616499Yonsei University35
终止
1 期
Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By SurgeryEsophageal CancerNCT00290719University of California, San Francisco6