Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
2022年3月23日 更新者：Alliance for Clinical Trials in Oncology
Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of bevacizumab in combination with sorafenib tosylate in patients with locally advanced or metastatic hepatocellular carcinoma. (Phase I closed to accrual as of 11/03/2010)
- Determine time to progression in these patients. (Phase II)
Secondary
- Determine the safety of this regimen in these patients. (Phase I closed to accrual as of 11/03/2010)
- Assess tolerability of this regimen in these patients. (Phase I closed to accrual as of 11/03/2010)
- Determine overall survival of these patients. (Phase II)
- Determine tumor response (at 6 months) in patients treated with this regimen. (Phase II)
- Determine progression-free survival of these patients. (Phase II)
- Determine response rate in patients treated with this regimen. (Phase II)
- Assess the occurrence of adverse events in these patients. (Phase II)
Tertiary
- Determine the relationship between tumor biomarkers and circulating biomarkers of vascular response and clinical outcome in patients treated with this regimen.
OUTLINE: This is a phase I, dose escalation study followed by a randomized phase II study.
- Phase I (closed to accrual as of 11/03/2010): Patients receive oral sorafenib tosylate twice daily on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients are stratified according to gender (female vs male), ECOG performance status (0 vs 1), and Child-Pugh class (A vs B7). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for analysis of circulating endothelial cells and circulating endothelial progenitor cells and angiogenic proteins in plasma by ELISA.
After completion of study treatment, patients are followed for 3 years.
研究类型
介入性
注册 (实际的)
24
阶段
- 阶段2
- 阶段1
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
-
-
Arizona
-
Scottsdale、Arizona、美国、85259-5499
- Mayo Clinic Scottsdale
-
-
Colorado
-
Aurora、Colorado、美国、80012
- Aurora Presbyterian Hospital
-
Boulder、Colorado、美国、80301-9019
- Boulder Community Hospital
-
Colorado Springs、Colorado、美国、80933
- Penrose Cancer Center at Penrose Hospital
-
Denver、Colorado、美国、80210
- Porter Adventist Hospital
-
Denver、Colorado、美国、80220
- Rose Medical Center
-
Denver、Colorado、美国、80218
- Presbyterian - St. Luke's Medical Center
-
Denver、Colorado、美国、80204
- St. Anthony Central Hospital
-
Denver、Colorado、美国、80218
- St. Joseph Hospital
-
Denver、Colorado、美国、80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood、Colorado、美国、80110
- Swedish Medical Center
-
Grand Junction、Colorado、美国、81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Greeley、Colorado、美国、80631
- North Colorado Medical Center
-
Lone Tree、Colorado、美国、80124
- Sky Ridge Medical Center
-
Longmont、Colorado、美国、80501
- Hope Cancer Care Center at Longmont United Hospital
-
Loveland、Colorado、美国、80539
- McKee Medical Center
-
Pueblo、Colorado、美国、81004
- St. Mary - Corwin Regional Medical Center
-
Thornton、Colorado、美国、80229
- North Suburban Medical Center
-
Wheat Ridge、Colorado、美国、80033
- Exempla Lutheran Medical Center
-
-
Connecticut
-
Hartford、Connecticut、美国、06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
-
-
Illinois
-
Bloomington、Illinois、美国、61701
- Illinois CancerCare - Bloomington
-
Bloomington、Illinois、美国、61701
- St. Joseph Medical Center
-
Canton、Illinois、美国、61520
- Illinois CancerCare - Canton
-
Canton、Illinois、美国、61520
- Graham Hospital
-
Carthage、Illinois、美国、62321
- Memorial Hospital
-
Carthage、Illinois、美国、62321
- Illinois CancerCare - Carthage
-
Eureka、Illinois、美国、61530
- Illinois CancerCare - Eureka
-
Eureka、Illinois、美国、61530
- Eureka Community Hospital
-
Galesburg、Illinois、美国、61401
- Illinois CancerCare - Galesburg
-
Galesburg、Illinois、美国、61401
- Galesburg Clinic, PC
-
Havana、Illinois、美国、62644
- Mason District Hospital
-
Havana、Illinois、美国、62644
- Illinois CancerCare - Havana
-
Kewanee、Illinois、美国、61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb、Illinois、美国、61455
- Illinois CancerCare - Macomb
-
Macomb、Illinois、美国、61455
- Mcdonough District Hospital
-
Moline、Illinois、美国、61265
-
Moline、Illinois、美国、61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth、Illinois、美国、61462
- Illinois CancerCare - Monmouth
-
Monmouth、Illinois、美国、61462
- OSF Holy Family Medical Center
-
Normal、Illinois、美国、61761
- Bromenn Regional Medical Center
-
Normal、Illinois、美国、61761
- Community Cancer Center
-
Normal、Illinois、美国、61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa、Illinois、美国、61350
- Community Hospital of Ottawa
-
Ottawa、Illinois、美国、61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin、Illinois、美国、61554
- Cancer Treatment Center at Pekin Hospital
-
Pekin、Illinois、美国、61603
- Illinois CancerCare - Pekin
-
Peoria、Illinois、美国、61636
- Methodist Medical Center of Illinois
-
Peoria、Illinois、美国、61614
- Proctor Hospital
-
Peoria、Illinois、美国、61637
- OSF St. Francis Medical Center
-
Peoria、Illinois、美国、61615
- CCOP - Illinois Oncology Research Association
-
Peoria、Illinois、美国、61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru、Illinois、美国、61354
- Illinois CancerCare - Peru
-
Peru、Illinois、美国、61354
- Illinois Valley Community Hospital
-
Princeton、Illinois、美国、61356
- Perry Memorial Hospital
-
Princeton、Illinois、美国、61356
- Illinois CancerCare - Princeton
-
Spring Valley、Illinois、美国、61362
- Illinois CancerCare - Spring Valley
-
-
Iowa
-
Bettendorf、Iowa、美国、52722
-
Clive、Iowa、美国、50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Des Moines、Iowa、美国、50309
- CCOP - Iowa Oncology Research Association
-
Des Moines、Iowa、美国、50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines、Iowa、美国、50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines、Iowa、美国、50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines、Iowa、美国、50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines、Iowa、美国、50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City、Iowa、美国、51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City、Iowa、美国、51104
- St. Luke's Regional Medical Center
-
Sioux City、Iowa、美国、51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute、Kansas、美国、66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City、Kansas、美国、67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado、Kansas、美国、67042
- Cancer Center of Kansas, PA - El Dorado
-
Fort Scott、Kansas、美国、66701
- Cancer Center of Kansas - Fort Scott
-
Independence、Kansas、美国、67301
- Cancer Center of Kansas-Independence
-
Kingman、Kansas、美国、67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence、Kansas、美国、66044
- Lawrence Memorial Hospital
-
Liberal、Kansas、美国、67905
- Cancer Center of Kansas, PA - Liberal
-
Newton、Kansas、美国、67114
- Cancer Center of Kansas, PA - Newton
-
Parsons、Kansas、美国、67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt、Kansas、美国、67124
- Cancer Center of Kansas, PA - Pratt
-
Salina、Kansas、美国、67401
- Cancer Center of Kansas, PA - Salina
-
Wellington、Kansas、美国、67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita、Kansas、美国、67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita、Kansas、美国、67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita、Kansas、美国、67214
- CCOP - Wichita
-
Wichita、Kansas、美国、67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita、Kansas、美国、67208
- Associates in Womens Health, PA - North Review
-
Winfield、Kansas、美国、67156
- Cancer Center of Kansas, PA - Winfield
-
-
Michigan
-
Ann Arbor、Michigan、美国、48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor、Michigan、美国、48106
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek、Michigan、美国、49017
- Battle Creek Health System Cancer Care Center
-
Big Rapids、Michigan、美国、49307
- Mecosta County Medical Center
-
Dearborn、Michigan、美国、48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Escanaba、Michigan、美国、49431
- Green Bay Oncology, Limited - Escanaba
-
Flint、Michigan、美国、48503
- Hurley Medical Center
-
Flint、Michigan、美国、48503
- Genesys Hurley Cancer Institute
-
Grand Rapids、Michigan、美国、49503
- Butterworth Hospital at Spectrum Health
-
Grand Rapids、Michigan、美国、49503
- CCOP - Grand Rapids
-
Grand Rapids、Michigan、美国、49503
- Lacks Cancer Center at Saint Mary's Health Care
-
Grosse Pointe Woods、Michigan、美国、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain、Michigan、美国、49801
- Dickinson County Healthcare System
-
Jackson、Michigan、美国、49201
- Foote Memorial Hospital
-
Lansing、Michigan、美国、48912-1811
- Sparrow Regional Cancer Center
-
Livonia、Michigan、美国、48154
- St. Mary Mercy Hospital
-
Muskegon、Michigan、美国、49443
- Mercy General Health Partners
-
Pontiac、Michigan、美国、48341-2985
- St. Joseph Mercy Oakland
-
Port Huron、Michigan、美国、48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw、Michigan、美国、48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Traverse City、Michigan、美国、49684
- Munson Medical Center
-
Warren、Michigan、美国、48093
- St. John Macomb Hospital
-
Wyoming、Michigan、美国、49519
- Metro Health Hospital
-
-
Minnesota
-
Bemidji、Minnesota、美国、56601
- MeritCare Bemidji
-
Burnsville、Minnesota、美国、55337
- Fairview Ridges Hospital
-
Coon Rapids、Minnesota、美国、55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth、Minnesota、美国、55805
- CCOP - Duluth
-
Duluth、Minnesota、美国、55805-1983
- Duluth Clinic Cancer Center - Duluth
-
Duluth、Minnesota、美国、55805
- Miller - Dwan Medical Center
-
Edina、Minnesota、美国、55435
- Fairview Southdale Hospital
-
Fergus Falls、Minnesota、美国、56537
- Fergus Falls Medical Group, PA
-
Fridley、Minnesota、美国、55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson、Minnesota、美国、55350
- Hutchinson Area Health Care
-
Maplewood、Minnesota、美国、55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood、Minnesota、美国、55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis、Minnesota、美国、55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis、Minnesota、美国、55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale、Minnesota、美国、55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
-
Saint Louis Park、Minnesota、美国、55416
- CCOP - Metro-Minnesota
-
Saint Louis Park、Minnesota、美国、55416
- Park Nicollet Cancer Center
-
Saint Paul、Minnesota、美国、55102
- United Hospital
-
Saint Paul、Minnesota、美国、55101
- Regions Hospital Cancer Care Center
-
Shakopee、Minnesota、美国、55379
- St. Francis Cancer Center at St. Francis Medical Center
-
Stillwater、Minnesota、美国、55082
- Lakeview Hospital
-
Waconia、Minnesota、美国、55387
- Ridgeview Medical Center
-
Willmar、Minnesota、美国、56201
- Willmar Cancer Center at Rice Memorial Hospital
-
Woodbury、Minnesota、美国、55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Missouri
-
Jefferson City、Missouri、美国、65109
- Goldschmidt Cancer Center
-
Saint Louis、Missouri、美国、63131
- Missouri Baptist Cancer Center
-
Saint Louis、Missouri、美国、63141
- Comprehensive Cancer Care, PC
-
-
Montana
-
Billings、Montana、美国、59101
- CCOP - Montana Cancer Consortium
-
Billings、Montana、美国、59101
- St. Vincent Healthcare Cancer Care Services
-
Billings、Montana、美国、59107-7000
- Billings Clinic - Downtown
-
Billings、Montana、美国、59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Bozeman、Montana、美国、59715
- Bozeman Deaconess Cancer Center
-
Butte、Montana、美国、59701
- St. James Healthcare Cancer Care
-
Great Falls、Montana、美国、59405
- Great Falls Clinic - Main Facility
-
Great Falls、Montana、美国、59405
- Sletten Cancer Institute at Benefis Healthcare
-
Havre、Montana、美国、59501
- Northern Montana Hospital
-
Helena、Montana、美国、59601
- St. Peter's Hospital
-
Kalispell、Montana、美国、59901
- Kalispell Regional Medical Center
-
Kalispell、Montana、美国、59901
- Glacier Oncology, PLLC
-
Kalispell、Montana、美国、59901
- Kalispell Medical Oncology at KRMC
-
Missoula、Montana、美国、59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula、Montana、美国、59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
North Dakota
-
Bismarck、North Dakota、美国、58501
- Bismarck Cancer Center
-
Bismarck、North Dakota、美国、58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck、North Dakota、美国、58501
- Mid Dakota Clinic, PC
-
Bismarck、North Dakota、美国、58502
- St. Alexius Medical Center Cancer Center
-
Fargo、North Dakota、美国、58122
- CCOP - MeritCare Hospital
-
Fargo、North Dakota、美国、58122
- MeritCare Broadway
-
-
Oklahoma
-
Tulsa、Oklahoma、美国、74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton、Pennsylvania、美国、18201
- Geisinger Hazleton Cancer Center
-
State College、Pennsylvania、美国、16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre、Pennsylvania、美国、18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Dakota
-
Rapid City、South Dakota、美国、57701
- Rapid City Regional Hospital
-
Sioux Falls、South Dakota、美国、57105
- Medical X-Ray Center, PC
-
Sioux Falls、South Dakota、美国、57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Wisconsin
-
Green Bay、Wisconsin、美国、54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay、Wisconsin、美国、54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay、Wisconsin、美国、54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay、Wisconsin、美国、54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc、Wisconsin、美国、54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette、Wisconsin、美国、54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls、Wisconsin、美国、54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sheboygan、Wisconsin、美国、53081
- St. Nicholas Hospital
-
Sturgeon Bay、Wisconsin、美国、54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
-
Wyoming
-
Casper、Wyoming、美国、82609
- Rocky Mountain Oncology
-
Sheridan、Wyoming、美国、82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
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 至 120年 (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
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular carcinoma
- Locally advanced or metastatic disease that is not amenable to treatment with surgery or to orthotopic liver transplant
- Child Pugh class A or B7 disease
- Measurable disease
- No mixed cholangiocarcinoma/hepatocellular carcinoma
- No current or previously resected brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,200/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Urine protein ≤ 1+ by urine protein:creatinine ratio OR 24-hour urine protein < 1 g
- QTc interval ≤ 500 msec on baseline EKG
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 2 weeks after sorafenib tosylate and 6 months after bevacizumab
None of the following risk factors for decreased LVEF:
- Prior treatment with anthracyclines
- History of myocardial infarction within the past 12 months
- No uncontrolled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management
- No New York Heart Association class III-IV congestive heart failure
- No cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- No history of hypertensive crisis or hypertensive encephalopathy
- No cardiac ventricular arrhythmia requiring anti-arrhythmic therapy within the past 6 months
None of the following within the past 6 months:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina or angina
- Clinically significant peripheral artery disease (i.e., claudication in less than one block) or any other arterial thrombotic event
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis
- No active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
- No evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)
- No significant traumatic injury within the past 4 weeks
- No serious or non-healing wound, ulcer, or bone fracture
- No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- No other active malignancy within the past 3 years, except nonmelanotic skin cancer or carcinoma in situ of the cervix
- No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or sorafenib tosylate
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy regimens for hepatocellular carcinoma
- No prior external beam radiation to the primary site
- No prior central thoracic radiation therapy (RT), including RT to the heart
- No prior radiation (if given for another malignancy) to ≥ 25% of the bone marrow
- At least 6 weeks since prior chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies
- More than 4 weeks since prior biologic, hormonal, or immune therapy
- More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
- More than 7 days since prior core biopsy or other minor surgical procedure (placement of a vascular access device allowed)
- No concurrent investigational agent which would be considered as a treatment for the primary neoplasm
- No concurrent anticoagulants, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis
- No other concurrent treatment for prior malignancy (other than hormonal therapy)
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：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 (Phase II)
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
鉴于IV
口头给予
|
|
实验性的：Arm II (Phase II)
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
口头给予
|
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 |
|---|---|---|
|
Maximum Tolerated Dose (Phase I)
大体时间：From baseline up to 3 years post treatment
|
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table.
The number of dose limiting toxicities will be reported here.
|
From baseline up to 3 years post treatment
|
|
Time to Progression (TTP) (Phase II)
大体时间：From baseline up to 3 years post treatment
|
Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up.
If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Kaplan-Meier survival curves will be used to estimate the distribution of TTP.
|
From baseline up to 3 years post treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：Up to 3 years post treatment
|
Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.
Kaplan-Meier survival curves will be used to estimate the distribution of OS.
|
Up to 3 years post treatment
|
|
Tumor Response at 6 Months
大体时间：6 months
|
Tumor response (at 6 months) is defined as the number of responses (complete or partial response per Section 11) over the number of eligible patients observed for at least 6 months.
Tumor response will be evaluated using simple estimates of proportions.
|
6 months
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2009年4月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2013年5月1日
研究注册日期
首次提交
2009年3月20日
首先提交符合 QC 标准的
2009年3月20日
首次发布 (估计)
2009年3月23日
研究记录更新
最后更新发布 (实际的)
2022年4月19日
上次提交的符合 QC 标准的更新
2022年3月23日
最后验证
2022年3月1日
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
- NCCTG-N0745
- NCI-2009-01178 (注册表标识符：CTRP (Clinical Trials Reporting System))
- CDR0000637866 (注册表标识符：PDQ (Physician Data Query))
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.
贝伐单抗的临床试验
-
Weill Medical College of Cornell University终止多形性胶质母细胞瘤 | 间变性星形细胞瘤 | 弥漫性脑桥脑胶质瘤 | 脑干胶质瘤 | 毛粘液样星形细胞瘤 | 脑干胶质瘤 | 脑纤维星形细胞瘤 | 混合性少突胶质细胞瘤-星形细胞瘤美国
-
Zhejiang Cancer Hospital招聘中
-
Sixth Affiliated Hospital, Sun Yat-sen University招聘中