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Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery

2018年4月30日 更新者：Alliance for Clinical Trials in Oncology

A Randomized Phase II Trial of Temozolomide (TMZ) and Bevacizumab or ABI-007 (ABX)/Carboplatin (CBDCA) and Bevacizumab in Patients With Unresectable Stage IV Malignant Melanoma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, paclitaxel albumin-stabilized nanoparticle formulation, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. It is not yet known whether bevacizumab is more effective when given together with temozolomide or paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in killing malignant melanoma cells.

PURPOSE: This randomized phase II trial is studying the side effects of giving temozolomide together with bevacizumab and to see how well it works compared with giving bevacizumab together with paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in treating patients with stage IV malignant melanoma that cannot be removed by surgery.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • To assess the anti-tumor activity, in terms of the percentage of patients who are treated with these regimens and who are progression-free at 6 months.
  • To assess the safety profile of each treatment regimen.

Secondary

  • To estimate the response rate in patients treated with these regimens.
  • To estimate the distribution of progression-free survival time and overall survival time of patients treated with these regimens.

Tertiary

  • To examine the impact of therapy on angiogenesis and immune homeostasis.

OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1) and location of metastatic disease (M1a [skin or subcutaneous tissue or lymph node only] vs M1b [lung] vs M1c [other visceral sites]) and randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual 8/21/09)
  • Arm II: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for VEGF plasma levels and analysis of changes in immune homeostasis.

Beginning at study entry, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.

研究类型

介入性

注册 (实际的)

95

阶段

  • 阶段2

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

  • 美国
    • Alaska
      • Anchorage、Alaska、美国、99508
        • Providence Cancer Center
    • 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
      • Fort Collins、Colorado、美国、80528
        • Front Range Cancer Specialists
      • 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
    • Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic - Jacksonville
    • 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
        • Illinois CancerCare - Carthage
      • Eureka、Illinois、美国、61530
        • Illinois CancerCare - Eureka
      • Eureka、Illinois、美国、61530
        • Eureka Community Hospital
      • Galesburg、Illinois、美国、61401
        • Galesburg Cottage Hospital
      • 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
      • Spring Valley、Illinois、美国、61362
        • St. Margaret's Hospital
    • Indiana
      • Beech Grove、Indiana、美国、46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Elkhart、Indiana、美国、46515
        • Elkhart General Hospital
      • Kokomo、Indiana、美国、46904
        • Howard Community Hospital
      • La Porte、Indiana、美国、46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Richmond、Indiana、美国、47374
        • Reid Hospital & Health Care Services
      • South Bend、Indiana、美国、46601
        • Memorial Hospital of South Bend
      • South Bend、Indiana、美国、46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend、Indiana、美国、46617
        • Saint Joseph Regional Medical Center
      • South Bend、Indiana、美国、46617
        • South Bend Clinic
    • Iowa
      • Ames、Iowa、美国、50010
        • McFarland Clinic, PC
      • Bettendorf、Iowa、美国、52722
      • Cedar Rapids、Iowa、美国、52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids、Iowa、美国、52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • 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
      • Des Moines、Iowa、美国、50307
        • Mercy Capitol Hospital
      • Mason City、Iowa、美国、50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Ottumwa、Iowa、美国、52501
        • McCreery Cancer Center at Ottumwa Regional
      • 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
      • Anthony、Kansas、美国、67003
        • Hospital District Sixth of Harper County
      • 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、67901
        • Southwest Medical Center
      • 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、67042
        • 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
      • Adrian、Michigan、美国、49221
        • Hickman Cancer Center at Bixby Medical Center
      • 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
      • Lambertville、Michigan、美国、48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Lansing、Michigan、美国、48912-1811
        • Sparrow Regional Cancer Center
      • Livonia、Michigan、美国、48154
        • St. Mary Mercy Hospital
      • Monroe、Michigan、美国、48162
        • Community Cancer Center of Monroe
      • Monroe、Michigan、美国、48162
        • Mercy Memorial Hospital - Monroe
      • 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
      • Saint Joseph、Michigan、美国、49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • 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
      • Alexandria、Minnesota、美国、56308
      • 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
      • 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 Cloud、Minnesota、美国、56303
        • CentraCare Clinic - River Campus
      • Saint Cloud、Minnesota、美国、56303
        • Coborn 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
      • Waconia、Minnesota、美国、55387
        • Ridgeview Medical Center
      • Woodbury、Minnesota、美国、55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Missouri
      • Saint Louis、Missouri、美国、63131
        • Missouri Baptist Cancer Center
      • Saint Louis、Missouri、美国、63141
        • Arch Medical Services, Incorporated at Center for Cancer Care and Research
      • Springfield、Missouri、美国、65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield、Missouri、美国、65804
        • St. John's Regional Health Center
      • Springfield、Missouri、美国、65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
      • Billings、Montana、美国、59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings、Montana、美国、59101
        • Northern Rockies Radiation Oncology Center
      • Billings、Montana、美国、59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings、Montana、美国、59107-7000
        • Billings Clinic - Downtown
      • 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
      • 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、59801
        • Community Medical Center
      • Missoula、Montana、美国、59804
        • Guardian Oncology and Center for Wellness
      • 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
    • Nebraska
      • Lincoln、Nebraska、美国、68510
        • Cancer Resource Center - Lincoln
      • Omaha、Nebraska、美国、68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha、Nebraska、美国、68122
        • Immanuel Medical Center
      • Omaha、Nebraska、美国、68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha、Nebraska、美国、68131-2197
        • Creighton University Medical Center
    • North Carolina
      • Rutherfordton、North Carolina、美国、28139
        • Rutherford Hospital
    • 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
      • Grand Forks、North Dakota、美国、58201
        • Altru Cancer Center at Altru Hospital
    • Ohio
      • Bellefontaine、Ohio、美国、43311
        • Mary Rutan Hospital
      • Bowling Green、Ohio、美国、43402
        • Wood County Oncology Center
      • Chillicothe、Ohio、美国、45601
        • Adena Regional Medical Center
      • Clyde、Ohio、美国、43410
        • North Coast Cancer Care - Clyde
      • Columbus、Ohio、美国、43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus、Ohio、美国、43222
        • Mount Carmel Health - West Hospital
      • Columbus、Ohio、美国、43215
        • CCOP - Columbus
      • Columbus、Ohio、美国、43215
        • Grant Medical Center Cancer Care
      • Columbus、Ohio、美国、43228
        • Doctors Hospital at Ohio Health
      • Dayton、Ohio、美国、45405
        • Grandview Hospital
      • Dayton、Ohio、美国、45406
        • Good Samaritan Hospital
      • Dayton、Ohio、美国、45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton、Ohio、美国、45415
        • Samaritan North Cancer Care Center
      • Dayton、Ohio、美国、45420
        • CCOP - Dayton
      • Delaware、Ohio、美国、43015
        • Grady Memorial Hospital
      • Elyria、Ohio、美国、44035
        • Hematology Oncology Center
      • Findlay、Ohio、美国、45840
        • Blanchard Valley Medical Associates
      • Franklin、Ohio、美国、45005-1066
        • Middletown Regional Hospital
      • Greenville、Ohio、美国、45331
        • Wayne Hospital
      • Kettering、Ohio、美国、45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster、Ohio、美国、43130
        • Fairfield Medical Center
      • Lima、Ohio、美国、45804
        • Lima Memorial Hospital
      • Marietta、Ohio、美国、45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee、Ohio、美国、43537
        • St. Luke's Hospital
      • Maumee、Ohio、美国、43537-1839
        • Northwest Ohio Oncology Center
      • Newark、Ohio、美国、43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon、Ohio、美国、43616
        • St. Charles Mercy Hospital
      • Oregon、Ohio、美国、43616
        • Toledo Clinic - Oregon
      • Sandusky、Ohio、美国、44870
        • North Coast Cancer Care, Incorporated
      • Springfield、Ohio、美国、45505
        • Community Hospital of Springfield and Clark County
      • Springfield、Ohio、美国、45504
        • Mercy Medical Center
      • Sylvania、Ohio、美国、43560
        • Flower Hospital Cancer Center
      • Tiffin、Ohio、美国、44883
        • Mercy Hospital of Tiffin
      • Toledo、Ohio、美国、43608
        • St. Vincent Mercy Medical Center
      • Toledo、Ohio、美国、43606
        • Toledo Hospital
      • Toledo、Ohio、美国、43614
        • Medical University of Ohio Cancer Center
      • Toledo、Ohio、美国、43617
        • CCOP - Toledo Community Hospital
      • Toledo、Ohio、美国、43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo、Ohio、美国、43623
        • St. Anne Mercy Hospital
      • Troy、Ohio、美国、45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon、Ohio、美国、43567
        • Fulton County Health Center
      • Westerville、Ohio、美国、43081
        • Mount Carmel St. Ann's Cancer Center
      • Wilmington、Ohio、美国、45177
        • Clinton Memorial Hospital
      • Xenia、Ohio、美国、45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Zanesville、Ohio、美国、43701
        • Genesis - Good Samaritan Hospital
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • 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 Carolina
      • Anderson、South Carolina、美国、29621
        • AnMed Cancer Center
      • Spartanburg、South Carolina、美国、29303
        • CCOP - Upstate Carolina
      • Spartanburg、South Carolina、美国、29303
        • Gibbs Regional Cancer Center at Spartanburg Regional 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
    • Virginia
      • Fredericksburg、Virginia、美国、22401
        • Fredericksburg Oncology, Incorporated
    • 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
      • 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
      • 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 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

  • Histologic confirmed diagnosis of malignant melanoma

    • Stage IV disease
    • Not amenable tosurgery

  • Measurable disease with at least one lesion whose longest diameter canbe measured as ≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT

    • No disease that is measurable by physical examination only
  • No brain metastases per MRI or CT
  • No radiographically documented invasion of adjacent organs(duodenum, stomach, etc.) or tumor invading major blood vessels
  • ECOG performance status 0-1
  • Life expectancy ≥ 4 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL (transfusion allowed)
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Urine protein:creatinine ratio < 1.0 at screening ORproteinuria < 2+ by urine dipstick or protein ≤ 1 g by 24-hour urine collection
  • Negative serum pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Active infection requiring parenteral antibiotics
  • Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or100 mm Hg diastolic) despite treatment
  • NYHA class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Myocardial infarction or unstable angina within the past 6 months
  • Clinically significant peripheral vascular disease
  • Deep venous thrombosis or pulmonary embolus within the past year
  • Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices)
  • Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
  • Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
  • History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)
  • Clinically significant stroke or TIA within the past 6 months
  • Seizures not controlled with standardmedical therapy
  • Peripheral neuropathy ≥ grade 2
  • History of other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treatable with local resection only or carcinoma in situ of the cervix
  • Significant traumatic injury within the past 4 weeks
  • History of hypertensive crisis or hypertensive encephalopathy
  • Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
  • Known hypersensitivity to any of the components of bevacizumab
  • Known to be HIV positive
  • Current or known history of hepatitis
  • Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed
  • No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,VEGF-trap, anti-VEGFR Mab)
  • No ongoing need for full-dose oral or parenteral anticoagulation
  • No ongoing anti-platelet treatment other than low-dose aspirin(i.e., aspirin 81 mg daily)
  • No other investigational agents within the past 4 weeks
  • No major surgical procedure or open biopsy within the past 4 weeks
  • No fine needle aspirations or core biopsies within the past 7 days
  • No prior chemotherapy in the metastatic setting
  • No prior treatment with sunitinib malate or sorafenib
  • No prior treatment with any taxane-based chemotherapy
  • Patients who have had > 25% of their functional bone marrow irradiated are not eligible for this trial
  • No adjuvant radiation therapy within the past 4 weeks
  • More than 2 weeks since prior and no concurrent palliative radiation therapy
  • No concurrent major surgical procedure
  • No concurrent participation in another clinical study for procedures or agents that treat the same primary study malignancy

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm I
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
生物：bevacizumab
Given IV over 30-90 minutes
药品：temozolomide
Oral temozolomide on days 1-5
实验性的：Arm II
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
生物：bevacizumab
Given IV over 30-90 minutes
药品：carboplatin
Given IV over 30 minutes
药品：paclitaxel albumin-stabilized nanoparticle formulation
Given IV over 30 minutes

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
Progression-free Survival at 6 Months
大体时间：at 6 months
The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate. Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria. Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death. All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.
at 6 months

次要结果测量

结果测量
措施说明
大体时间
Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval
大体时间：Up to 5 years

A confirmed tumor response is defined to be a Complete Response or Partial Response noted

> as the objective status on 2 consecutive evaluations at least 8

> weeks apart. The proportion of tumor responses will be

> estimated by the number of confirmed tumor responses divided

> by the total number of evaluable patients.

> Complete Response (CR): Disappearance of all target lesions

> Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

> Progression (PD): At least a 20% increase in the sum of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

> Stable Disease (SD): Neither sufficient shrinkage to Qualify for PR nor sufficient increase to Qualify for PD taking as reference the smallest sum LD. responses will be calculated assuming that the number of

> confirmed tumor responses follows a binomial distribution.
Up to 5 years
Overall Survival
大体时间：Up to 5 years
Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Up to 5 years

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。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

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。

一般刊物

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

2008年8月1日

初级完成 (实际的)

2010年7月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2008年2月28日

首先提交符合 QC 标准的

2008年2月28日

首次发布 (估计)

2008年2月29日

研究记录更新

最后更新发布 (实际的)

2018年5月1日

上次提交的符合 QC 标准的更新

2018年4月30日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NCCTG-N0775
  • NCI-2009-00667 (注册表标识符：CTRP (Clinical Trials Reporting System))
  • CDR0000587708 (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.

bevacizumab的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Macedonia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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