Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
2009年8月7日 更新者：Massachusetts General Hospital
A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil, Oxaliplatin, and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer (Phase II portion).
研究概览
地位
终止
详细说明
- The combination of all three drugs and radiation treatment has never been given to people before, therefore, we are going to add just one additional drug at a time for safety reasons.
- The first group of participants (3-4) who enroll on the study will receive 5-FU, radiation therapy with the added drug oxaliplatin, this is called Regimen level 1. If these participants have few or easily manageable side effects, then another group of participants will be enrolled and will receive 5-FU, radiation, oxaliplatin with the addition of bevacizumab this is called Regimen level 2.
- The combination of study drugs and radiation will last about 6 weeks, this 6 week period is called a cycle 1.
- Regimen Level 1 will receive the following: oxaliplatin intravenously on days 1, 8, 15, 22, 29, and 36; 5-FU infused by a continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy Monday-Friday to complete on day 38.
- Regimen Level 2 will receive the following; bevacizumab intravenously on days 1, 15, and 29; oxaliplatin intravenously on days 1, 8, 15, 22, 29 and 36; 5-FU infused by continuous infusion days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy Monday-Friday to complete on day day 38.
- The following are tests and procedures that will be performed during cycle 1: physical examination; blood work, urine sample. perfusion CT scan on day 12 (for those participants enrolled at Massachusetts General Hospital).
- At the end of cycle 1, CT scans will be performed to evaluate the participants disease status before they receive combination gemcitabine and bevacizumab. If the scans show the tumor has reduced in size and can be surgically removed, then surgery will be scheduled and the patient will receive gemcitabine and bevacizumab about 4 weeks after the surgery. If the scans show the tumor can not be removed, the patient will receive the gemcitabine/bevacizumab combination about 4 weeks after completing cycle 1.
- Cycles 2-5 consist of: gemcitabine given intravenously on days 1, 8, and 15 every 28 days; bevacizumab given intravenously on days 1 and 15 every 28 days. During cycles 2-5 the following tests and procedures will be performed: physical examination including vital signs on day 1 and 15 of each cycle; blood work on days 1, 8 and 15 of each cycle; a urine sample on day 1 of each cycle; CT scans will be done every 2 cycles.
- It will take about 7 months to complete the study treatment (longer for those who have surgery after Cycle 1).
研究类型
介入性
注册 (实际的)
52
阶段
- 阶段2
- 阶段1
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy
- Disease is measurable by CT scan
- Age >= to 18 years
- Life expectancy of 4 months or longer
- ANC >/= 1,500mm/cm3
- Hemoglobin >/= 9g/dl
- Platelet count >/= 100,000/cm3
- Total bilirubin </= 2 times control
- SGOT/SGPT </= 2.5 times upper limit of normal
- Serum creatinine < 2mg/dl
- No evidence of metastatic disease by laparoscopy
Exclusion Criteria:
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications
- No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years
- Patients with pre-existing peripheral neuropathy of grade 2 or greater
- Pregnant or lactating women
- Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study
- Blood pressure of >150/100 mmHg
- Unstable angina
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or stroke within 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
- Urine protein creatinine ratio > or = to 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
- Serious, non-healing wound, ulcer, or bone fracture
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：非随机化
- 介入模型：阶乘赋值
- 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：Regimen Level 1
Radiation/Oxaliplatin/5-FU
|
Intravenously on days 1, 15 and 29 of the first cycle.
Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
Monday through Friday ending on day 38 of cycle 1
|
|
实验性的：Regimen Level 2
Radiation/Oxaliplatin/Bevacizumab/5-FU
|
Intravenously on days 1, 15 and 29 of the first cycle.
Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
Monday through Friday ending on day 38 of cycle 1
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer
大体时间：2 years
|
2 years
|
|
to determine the survival of patients treated with this regimen.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To determine the progression free survival
|
|
|
to determine the rate of conversion to resectability after treatment
大体时间：2 years
|
2 years
|
|
to asses the duration of response and response rate of this combination and
|
|
|
to evaluate the toxicities.
大体时间：2 years
|
2 years
|
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。
调查人员
- 首席研究员：Lawrence S. Blaszkowsky, MD、Massachusetts General Hospital
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
2006年5月1日
初级完成 (实际的)
2007年8月1日
研究完成 (实际的)
2009年7月1日
研究注册日期
首次提交
2006年3月24日
首先提交符合 QC 标准的
2006年3月24日
首次发布 (估计)
2006年3月28日
研究记录更新
最后更新发布 (估计)
2009年8月10日
上次提交的符合 QC 标准的更新
2009年8月7日
最后验证
2009年8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.
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