Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212
- NSABP Operations Center
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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:
- Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
- Evidence of adequate organ function (such as liver, kidneys, etc.)
Exclusion Criteria:
- Diagnosis of anal cancer
- Patients who are candidates for surgery
- Patients who have received previous treatments
- Pregnant or lactating women
- History of chronic disease(s) or other serious medical conditions
学习计划
研究是如何设计的？
设计细节
- 主要用途：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 |
|---|---|
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实验性的：1个
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7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
其他名称：
130 mg/m2 IV Day 1 every 21 days for eight cycles
其他名称：
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
其他名称：
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实验性的：2个
|
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
其他名称：
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
其他名称：
200 mg/m2 IV Day 1 every 21 days for eight cycles
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 |
措施说明 |
大体时间 |
|---|---|---|
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One-year Progression-free Survival (PFS)
大体时间：Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Outcome measure was not assessed due to early study closure.
The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Objective Response Rate
大体时间：Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
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Toxicity - Adverse Events
大体时间：Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
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Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
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Overall Survival
大体时间：Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
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Duration of Response
大体时间：Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
合作者和调查者
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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