A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
2017年1月18日 更新者：Hoffmann-La Roche
An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum.
The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 第四阶段
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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-
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Chai Yi、台湾、613
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Kaohsiung、台湾、00833
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Kaohsiung、台湾、807
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Taichung、台湾、404
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Taichung、台湾、407
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Tainan、台湾、704
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Tainan、台湾、710
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Taipei、台湾、104
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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
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:
- Previously untreated metastatic colon or rectal cancer
- Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment
Exclusion Criteria:
- Prior chemotherapy for metastatic colon or rectal cancer
- Planned radiotherapy for underlying disease
- Central nervous system metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
- Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
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 + Chemotherapy
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study.
The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
其他名称：
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Adverse Events
大体时间：Baseline up to approximately 3 years
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An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
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Baseline up to approximately 3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants Who Died
大体时间：Baseline up to approximately 3 years
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Baseline up to approximately 3 years
|
|
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Duration of Survival
大体时间：Baseline up to approximately 3 years
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Duration of survival was defined as the time period from the start of first line therapy to death.
Duration of survival was estimated using Kaplan-Meier analysis.
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Baseline up to approximately 3 years
|
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Percentage of Participants With Disease Progression or Death
大体时间：Baseline up to approximately 3 years
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Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).
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Baseline up to approximately 3 years
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Progression-Free Survival Time
大体时间：Baseline up to approximately 3 years
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Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause.
Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL.
Progression-free survival was estimated using Kaplan-Meier analysis.
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Baseline up to approximately 3 years
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Number of Participants With Best Overall Response
大体时间：Baseline up to approximately 3 years
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The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL.
Complete response (CR): disappearance of all TL and non-TL.
If immunocytology was available, no disease was to be detected by that methodology.
Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.
Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.
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Baseline up to approximately 3 years
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Mean Direct Medical Cost for Cancer Related Medical Care Utilization
大体时间：Baseline up to approximately 3 years
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Direct medical cost included cost of out-patient consultation and cost of hospitalization.
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Baseline up to approximately 3 years
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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。
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
2005年5月1日
初级完成 (实际的)
2007年10月1日
研究完成 (实际的)
2008年4月1日
研究注册日期
首次提交
2015年10月12日
首先提交符合 QC 标准的
2015年10月20日
首次发布 (估计)
2015年10月21日
研究记录更新
最后更新发布 (实际的)
2017年3月9日
上次提交的符合 QC 标准的更新
2017年1月18日
最后验证
2017年1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.