Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
2012年7月31日 更新者:M.D. Anderson Cancer Center
A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer.
The effect that this combination treatment has on the tumor will also be studied.
研究概览
详细说明
This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab.
The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.
研究类型
介入性
注册 (实际的)
48
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Texas
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Houston、Texas、美国、77030
- University of Texas MDAnderson Cancer Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
- Patients with nonmetastatic, unresectable, disease are eligible.
- Patients with regional nodal disease are eligible.
- Karnofsky performance status >/=70.
- No upper age restriction.
- Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3.
- Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression.
- Adequate bilateral renal function.
- Serum creatinine <1.5 mg/dl.
- Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)</=5 times upper limit of normal.
- Sexually active men must practice contraception during study.
- Patients must sign study-specific consent form.
Exclusion Criteria:
- History or evidence upon physical examination of CNS disease.
- Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent.
- Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications.
- Pregnancy or lactation.
- Proteinuria at baseline or impairment of renal function.
- Serious, nonhealing wound, ulcer, or bone fracture.
- Evidence of bleeding diathesis or coagulopathy
- Clinically significant cardiovascular disease, congestive heart failure, serous cardiac arrhythmia requiring medication, or significant peripheral vascular disease within 1 year prior to Day 0.
- History of aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations.
- Serous concomitant medical or psychiatric disorders.
- Cohort receiving Capecitabine
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Bevacizumab
Radiation, Bevacizumab, and Capecitabine
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Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
其他名称:
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
其他名称:
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Safety of combination Radiation, Bevacizumab, and Capecitabine.
大体时间:6 weeks after the completion of therapy
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6 weeks after the completion of therapy
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To evaluate the local tumor response and median survival in patients treated with the above regimen.
大体时间:6 weeks after the completion of therapy.
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6 weeks after the completion of therapy.
|
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To evaluate VEGF serum levels before and after anti-VEGF therapy.
大体时间:6 weeks after the completion of therapy.
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6 weeks after the completion of therapy.
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To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy.
大体时间:6 weeks after the completion of therapy.
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6 weeks after the completion of therapy.
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To evaluate quality of life in patients receiving this therapy.
大体时间:6 weeks after the completion of therapy.
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6 weeks after the completion of therapy.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Christopher H. Crane, MD、M.D. Anderson Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年9月1日
初级完成 (实际的)
2006年7月1日
研究完成 (实际的)
2006年7月1日
研究注册日期
首次提交
2002年10月14日
首先提交符合 QC 标准的
2002年10月15日
首次发布 (估计)
2002年10月16日
研究记录更新
最后更新发布 (估计)
2012年8月1日
上次提交的符合 QC 标准的更新
2012年7月31日
最后验证
2012年7月1日
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.