Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (Avastin®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy
RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.
研究概览
详细说明
OBJECTIVES:
- Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens.
- Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36.
- Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44.
For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for tumor response and survival.
PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study. A total of 35-125 patients will be accrued for this study within 3 months.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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Alaska
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Anchorage、Alaska、美国、99519-6604
- Providence Alaska Medical Center
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California
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Los Angeles、California、美国、90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles、California、美国、90024
- Jonsson Comprehensive Cancer Center, UCLA
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Colorado
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Aurora、Colorado、美国、80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven、Connecticut、美国、06520-8028
- Yale Comprehensive Cancer Center
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District of Columbia
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Washington、District of Columbia、美国、20007
- Lombardi Cancer Center
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Georgia
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Atlanta、Georgia、美国、30342-1701
- CCOP - Atlanta Regional
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Illinois
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Chicago、Illinois、美国、60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Maywood、Illinois、美国、60153
- Loyola University Medical Center
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Iowa
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Iowa City、Iowa、美国、52242-1009
- Holden Comprehensive Cancer Center
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Sioux City、Iowa、美国、51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Maine
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Bangor、Maine、美国、04401
- Cancer Care of Maine
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Michigan
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Ann Arbor、Michigan、美国、48106
- Saint Joseph Mercy Health System
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Minnesota
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Duluth、Minnesota、美国、55805
- St. Mary's/Duluth Clinic Cancer Center
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Mississippi
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Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
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Montana
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Billings、Montana、美国、59101
- CCOP - Montana Cancer Consortium
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Nevada
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Las Vegas、Nevada、美国、89106
- Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon、New Hampshire、美国、03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
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New York、New York、美国、10021
- New York Weill Cornell Cancer Center at Cornell University
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North Carolina
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Winston-Salem、North Carolina、美国、27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo、North Dakota、美国、58122
- Meritcare Roger Maris Cancer Center
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Ohio
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Cleveland、Ohio、美国、44106-5065
- Ireland Cancer Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Dakota
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Sioux Falls、South Dakota、美国、57104
- Sioux Valley Clinics - Oncology
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Vermont
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Burlington、Vermont、美国、05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Richmond、Virginia、美国、23298-0037
- Massey Cancer Center
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Washington
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Seattle、Washington、美国、98109
- Seattle Cancer Care Alliance
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Seattle、Washington、美国、98101
- CCOP - Virginia Mason Research 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
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal adenocarcinoma
- Stage IV (metastatic) disease
- Not curable by surgery or radiotherapy
Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria:
- Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy
- Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
- No evidence of bleeding diathesis or coagulopathy
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST less than 5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 5 times ULN
- PT and INR no greater than 1.5 times ULN
- PTT no greater than ULN
Renal
- Creatinine no greater than 1.5 times ULN
- Proteinuria less than grade 1 OR
- Proteinuria less than 500 mg/24 hours
Cardiovascular
- No prior stroke
- No uncontrolled high blood pressure
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
- No thromboembolism within the past 6 months
Other
- Chemonaive
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No significant traumatic injury within the past 6 weeks
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents
- No active infection
- No psychiatric illness or social situation that would preclude study compliance
- No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
No CNS disease, including either of the following:
- Primary brain tumor
- Seizures not controlled with standard medical therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 8 weeks since prior monoclonal antibody therapy
- No prior bevacizumab
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
Surgery
- More than 6 weeks since prior major surgical procedure or open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
- No concurrent surgery
Other
- Recovered from prior therapy
- At least 3 weeks since prior cytotoxic agents
No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met
- No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents for the malignancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
合作者和调查者
调查人员
- 首席研究员:Helen X. Chen, MD、NCI - Investigational Drug Branch
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
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
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