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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

30. april 2018 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

95

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Cancer Center
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259-5499
        • Mayo Clinic Scottsdale
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, Forenede Stater, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Forenede Stater, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, Forenede Stater, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Forenede Stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, Forenede Stater, 80204
        • St. Anthony Central Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • St. Joseph Hospital
      • Denver, Colorado, Forenede Stater, 80224-2522
        • CCOP - Colorado Cancer Research Program
      • Englewood, Colorado, Forenede Stater, 80110
        • Swedish Medical Center
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Front Range Cancer Specialists
      • Grand Junction, Colorado, Forenede Stater, 81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Greeley, Colorado, Forenede Stater, 80631
        • North Colorado Medical Center
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Forenede Stater, 80501
        • Hope Cancer Care Center at Longmont United Hospital
      • Loveland, Colorado, Forenede Stater, 80539
        • McKee Medical Center
      • Pueblo, Colorado, Forenede Stater, 81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton, Colorado, Forenede Stater, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Exempla Lutheran Medical Center
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61701
        • Illinois CancerCare - Bloomington
      • Bloomington, Illinois, Forenede Stater, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare - Canton
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare - Carthage
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Illinois CancerCare - Havana
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare - Macomb
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, Forenede Stater, 61265
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Monmouth, Illinois, Forenede Stater, 61462
        • Illinois CancerCare - Monmouth
      • Monmouth, Illinois, Forenede Stater, 61462
        • OSF Holy Family Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center
      • Normal, Illinois, Forenede Stater, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forenede Stater, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Forenede Stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Pekin, Illinois, Forenede Stater, 61603
        • Illinois CancerCare - Pekin
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forenede Stater, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare - Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare - Princeton
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Illinois CancerCare - Spring Valley
      • Spring Valley, Illinois, Forenede Stater, 61362
        • St. Margaret's Hospital
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, Forenede Stater, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Hospital & Health Care Services
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Forenede Stater, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, Forenede Stater, 46617
        • South Bend Clinic
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic, PC
      • Bettendorf, Iowa, Forenede Stater, 52722
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Clive, Iowa, Forenede Stater, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Des Moines, Iowa, Forenede Stater, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Forenede Stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines, Iowa, Forenede Stater, 50307
        • Mercy Capitol Hospital
      • Mason City, Iowa, Forenede Stater, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, Forenede Stater, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Forenede Stater, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Anthony, Kansas, Forenede Stater, 67003
        • Hospital District Sixth of Harper County
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67901
        • Southwest Medical Center
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Forenede Stater, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Forenede Stater, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, Forenede Stater, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, Forenede Stater, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Forenede Stater, 49201
        • Foote Memorial Hospital
      • Lambertville, Michigan, Forenede Stater, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Lansing, Michigan, Forenede Stater, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Forenede Stater, 48154
        • St. Mary Mercy Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital - Monroe
      • Muskegon, Michigan, Forenede Stater, 49443
        • Mercy General Health Partners
      • Pontiac, Michigan, Forenede Stater, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, Forenede Stater, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
      • Warren, Michigan, Forenede Stater, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, Forenede Stater, 49519
        • Metro Health Hospital
    • Minnesota
      • Alexandria, Minnesota, Forenede Stater, 56308
      • Bemidji, Minnesota, Forenede Stater, 56601
        • MeritCare Bemidji
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Forenede Stater, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, Forenede Stater, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital Cancer Care Center
      • Shakopee, Minnesota, Forenede Stater, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care and Research
      • Springfield, Missouri, Forenede Stater, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Forenede Stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forenede Stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forenede Stater, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Forenede Stater, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Forenede Stater, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Forenede Stater, 59405
      • Havre, Montana, Forenede Stater, 59501
        • Northern Montana Hospital
      • Helena, Montana, Forenede Stater, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Forenede Stater, 59801
        • Community Medical Center
      • Missoula, Montana, Forenede Stater, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Forenede Stater, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Forenede Stater, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, Forenede Stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Forenede Stater, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68131-2197
        • Creighton University Medical Center
    • North Carolina
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Forenede Stater, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Forenede Stater, 58122
        • MeritCare Broadway
      • Grand Forks, North Dakota, Forenede Stater, 58201
        • Altru Cancer Center at Altru Hospital
    • Ohio
      • Bellefontaine, Ohio, Forenede Stater, 43311
        • Mary Rutan Hospital
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Wood County Oncology Center
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Clyde, Ohio, Forenede Stater, 43410
        • North Coast Cancer Care - Clyde
      • Columbus, Ohio, Forenede Stater, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital at Ohio Health
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Forenede Stater, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Forenede Stater, 45420
        • CCOP - Dayton
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, Forenede Stater, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Kettering, Ohio, Forenede Stater, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, Forenede Stater, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537
        • St. Luke's Hospital
      • Maumee, Ohio, Forenede Stater, 43537-1839
        • Northwest Ohio Oncology Center
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care, Incorporated
      • Springfield, Ohio, Forenede Stater, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, Forenede Stater, 45504
        • Mercy Medical Center
      • Sylvania, Ohio, Forenede Stater, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43606
        • Toledo Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Forenede Stater, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forenede Stater, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, Forenede Stater, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, Forenede Stater, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis - Good Samaritan Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Danville, Pennsylvania, Forenede Stater, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hazleton, Pennsylvania, Forenede Stater, 18201
        • Geisinger Hazleton Cancer Center
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology, Incorporated
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
Given IV over 30-90 minutes
Oral temozolomide on days 1-5
Eksperimentel: 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.
Given IV over 30-90 minutes
Given IV over 30 minutes
Given IV over 30 minutes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival at 6 Months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

28. februar 2008

Først indsendt, der opfyldte QC-kriterier

28. februar 2008

Først opslået (Skøn)

29. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2018

Sidst verificeret

1. april 2018

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Melanom (hud)

Kliniske forsøg med bevacizumab

Abonner