Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma
研究概览
地位
详细说明
PRIMARY OBJECTIVES:
I. To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine, before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.
II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer.
III. To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations.
SECONDARY OBJECTIVES:
I. To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.
II. To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation, or capecitabine plus bevacizumab plus radiation.
III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for patients receiving cetuximab.
IV. To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
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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Massachusetts
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Boston、Massachusetts、美国、02215
- Eastern Cooperative Oncology Group
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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:
- Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
- Patients must have had all gross disease resected (R0 or R1 resection)
- Patients undergoing an R2 resection are not eligible
- Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition
- Patient must have ECOG performance status of 0-2
- Leukocytes >= 3,000/μL
- ANC >= 1,500/μL
- Platelets >= 100,000/μL
- Total bilirubin Within normal institutional limits
- AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
- Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
- Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy)
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry
- Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- Patients must not be receiving any other investigational agents
- Patients with known metastases are not eligible
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible
- Patients with wounds that have not fully healed are not eligible
- Patients must not have cardiac arrhythmia
- Patients must have no known HIV infection
- Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
- Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
- Patients requiring full dose anticoagulation are not eligible
- Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible
Patients with a history of the following within twelve months of study entry are not eligible:
- Arterial thrombembolic events
- Unstable angina
- Myocardial infarction
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 |
|---|---|
|
实验性的：Arm I (cetuximab, gemcitabine, capecitabine, radiation)
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10.
Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
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相关研究
鉴于IV
其他名称：
鉴于IV
其他名称：
口头给予
其他名称：
接受放射治疗
其他名称：
|
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实验性的：Arm II (bevacizumab, gemcitabine, capecitabine, radiation)
Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23.
Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
|
相关研究
鉴于IV
其他名称：
鉴于IV
其他名称：
口头给予
其他名称：
接受放射治疗
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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Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
大体时间：Every 2 weeks while on treatment and for 30 days after the end of treatment
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Specific toxicities to be monitored pursuant to the primary endpoint include:
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Every 2 weeks while on treatment and for 30 days after the end of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Two-year Overall Survival Rate
大体时间：Assessed every 3 months for 2 years
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Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.
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Assessed every 3 months for 2 years
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Two-year Disease-free Survival (DFS)
大体时间：Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
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Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).
|
Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
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合作者和调查者
调查人员
- 首席研究员：Jordan Berlin、Eastern Cooperative Oncology Group
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NCI-2012-02969 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- U10CA021115 (美国 NIH 拨款/合同)
- CALGB-ECOG-E2204
- SWOG-ECOG-E2204
- ECOG-E2204
- NCCTG-ECOG-E2204
- E2204 (其他标识符：CTEP)
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