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
2018년 4월 30일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
95
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alaska
-
Anchorage, Alaska, 미국, 99508
- Providence Cancer Center
-
-
Arizona
-
Scottsdale, Arizona, 미국, 85259-5499
- Mayo Clinic Scottsdale
-
-
Colorado
-
Aurora, Colorado, 미국, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, 미국, 80301-9019
- Boulder Community Hospital
-
Colorado Springs, Colorado, 미국, 80933
- Penrose Cancer Center at Penrose Hospital
-
Denver, Colorado, 미국, 80210
- Porter Adventist Hospital
-
Denver, Colorado, 미국, 80220
- Rose Medical Center
-
Denver, Colorado, 미국, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, 미국, 80204
- St. Anthony Central Hospital
-
Denver, Colorado, 미국, 80218
- St. Joseph Hospital
-
Denver, Colorado, 미국, 80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood, Colorado, 미국, 80110
- Swedish Medical Center
-
Fort Collins, Colorado, 미국, 80528
- Front Range Cancer Specialists
-
Grand Junction, Colorado, 미국, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Greeley, Colorado, 미국, 80631
- North Colorado Medical Center
-
Lone Tree, Colorado, 미국, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, 미국, 80501
- Hope Cancer Care Center at Longmont United Hospital
-
Loveland, Colorado, 미국, 80539
- McKee Medical Center
-
Pueblo, Colorado, 미국, 81004
- St. Mary - Corwin Regional Medical Center
-
Thornton, Colorado, 미국, 80229
- North Suburban Medical Center
-
Wheat Ridge, Colorado, 미국, 80033
- Exempla Lutheran Medical Center
-
-
Florida
-
Jacksonville, Florida, 미국, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Bloomington, Illinois, 미국, 61701
- Illinois CancerCare - Bloomington
-
Bloomington, Illinois, 미국, 61701
- St. Joseph Medical Center
-
Canton, Illinois, 미국, 61520
- Illinois CancerCare - Canton
-
Canton, Illinois, 미국, 61520
- Graham Hospital
-
Carthage, Illinois, 미국, 62321
- Illinois CancerCare - Carthage
-
Eureka, Illinois, 미국, 61530
- Illinois CancerCare - Eureka
-
Eureka, Illinois, 미국, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, 미국, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, 미국, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, 미국, 62644
- Mason District Hospital
-
Havana, Illinois, 미국, 62644
- Illinois CancerCare - Havana
-
Kewanee, Illinois, 미국, 61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb, Illinois, 미국, 61455
- Illinois CancerCare - Macomb
-
Macomb, Illinois, 미국, 61455
- Mcdonough District Hospital
-
Moline, Illinois, 미국, 61265
-
Moline, Illinois, 미국, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth, Illinois, 미국, 61462
- Illinois CancerCare - Monmouth
-
Monmouth, Illinois, 미국, 61462
- OSF Holy Family Medical Center
-
Normal, Illinois, 미국, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, 미국, 61761
- Community Cancer Center
-
Normal, Illinois, 미국, 61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa, Illinois, 미국, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, 미국, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, 미국, 61554
- Cancer Treatment Center at Pekin Hospital
-
Pekin, Illinois, 미국, 61603
- Illinois CancerCare - Pekin
-
Peoria, Illinois, 미국, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, 미국, 61614
- Proctor Hospital
-
Peoria, Illinois, 미국, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, 미국, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, 미국, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, 미국, 61354
- Illinois CancerCare - Peru
-
Peru, Illinois, 미국, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, 미국, 61356
- Perry Memorial Hospital
-
Princeton, Illinois, 미국, 61356
- Illinois CancerCare - Princeton
-
Spring Valley, Illinois, 미국, 61362
- Illinois CancerCare - Spring Valley
-
Spring Valley, Illinois, 미국, 61362
- St. Margaret's Hospital
-
-
Indiana
-
Beech Grove, Indiana, 미국, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Elkhart, Indiana, 미국, 46515
- Elkhart General Hospital
-
Kokomo, Indiana, 미국, 46904
- Howard Community Hospital
-
La Porte, Indiana, 미국, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
-
Richmond, Indiana, 미국, 47374
- Reid Hospital & Health Care Services
-
South Bend, Indiana, 미국, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, 미국, 46601
- CCOP - Northern Indiana CR Consortium
-
South Bend, Indiana, 미국, 46617
- Saint Joseph Regional Medical Center
-
South Bend, Indiana, 미국, 46617
- South Bend Clinic
-
-
Iowa
-
Ames, Iowa, 미국, 50010
- McFarland Clinic, PC
-
Bettendorf, Iowa, 미국, 52722
-
Cedar Rapids, Iowa, 미국, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, 미국, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
-
Clive, Iowa, 미국, 50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Des Moines, Iowa, 미국, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, 미국, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, 미국, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, 미국, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, 미국, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, 미국, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, 미국, 50307
- Mercy Capitol Hospital
-
Mason City, Iowa, 미국, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Ottumwa, Iowa, 미국, 52501
- McCreery Cancer Center at Ottumwa Regional
-
Sioux City, Iowa, 미국, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, 미국, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, 미국, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Anthony, Kansas, 미국, 67003
- Hospital District Sixth of Harper County
-
Chanute, Kansas, 미국, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, 미국, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, 미국, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Fort Scott, Kansas, 미국, 66701
- Cancer Center of Kansas - Fort Scott
-
Independence, Kansas, 미국, 67301
- Cancer Center of Kansas-Independence
-
Kingman, Kansas, 미국, 67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence, Kansas, 미국, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, 미국, 67901
- Southwest Medical Center
-
Newton, Kansas, 미국, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, 미국, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, 미국, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, 미국, 67042
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, 미국, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, 미국, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, 미국, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, 미국, 67214
- CCOP - Wichita
-
Wichita, Kansas, 미국, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, 미국, 67208
- Associates in Womens Health, PA - North Review
-
Winfield, Kansas, 미국, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Michigan
-
Adrian, Michigan, 미국, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Ann Arbor, Michigan, 미국, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, 미국, 48106
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek, Michigan, 미국, 49017
- Battle Creek Health System Cancer Care Center
-
Big Rapids, Michigan, 미국, 49307
- Mecosta County Medical Center
-
Dearborn, Michigan, 미국, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Escanaba, Michigan, 미국, 49431
- Green Bay Oncology, Limited - Escanaba
-
Flint, Michigan, 미국, 48503
- Hurley Medical Center
-
Flint, Michigan, 미국, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, 미국, 49503
- Butterworth Hospital at Spectrum Health
-
Grand Rapids, Michigan, 미국, 49503
- CCOP - Grand Rapids
-
Grand Rapids, Michigan, 미국, 49503
- Lacks Cancer Center at Saint Mary's Health Care
-
Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain, Michigan, 미국, 49801
- Dickinson County Healthcare System
-
Jackson, Michigan, 미국, 49201
- Foote Memorial Hospital
-
Lambertville, Michigan, 미국, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Lansing, Michigan, 미국, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, 미국, 48154
- St. Mary Mercy Hospital
-
Monroe, Michigan, 미국, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, 미국, 48162
- Mercy Memorial Hospital - Monroe
-
Muskegon, Michigan, 미국, 49443
- Mercy General Health Partners
-
Pontiac, Michigan, 미국, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, 미국, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, 미국, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Saint Joseph, Michigan, 미국, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
-
Traverse City, Michigan, 미국, 49684
- Munson Medical Center
-
Warren, Michigan, 미국, 48093
- St. John Macomb Hospital
-
Wyoming, Michigan, 미국, 49519
- Metro Health Hospital
-
-
Minnesota
-
Alexandria, Minnesota, 미국, 56308
-
Bemidji, Minnesota, 미국, 56601
- MeritCare Bemidji
-
Burnsville, Minnesota, 미국, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, 미국, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth, Minnesota, 미국, 55805
- CCOP - Duluth
-
Duluth, Minnesota, 미국, 55805-1983
- Duluth Clinic Cancer Center - Duluth
-
Duluth, Minnesota, 미국, 55805
- Miller - Dwan Medical Center
-
Edina, Minnesota, 미국, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, 미국, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, 미국, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, 미국, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, 미국, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, 미국, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, 미국, 55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale, Minnesota, 미국, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, 미국, 56303
- CentraCare Clinic - River Campus
-
Saint Cloud, Minnesota, 미국, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, 미국, 55416
- CCOP - Metro-Minnesota
-
Saint Louis Park, Minnesota, 미국, 55416
- Park Nicollet Cancer Center
-
Saint Paul, Minnesota, 미국, 55102
- United Hospital
-
Saint Paul, Minnesota, 미국, 55101
- Regions Hospital Cancer Care Center
-
Shakopee, Minnesota, 미국, 55379
- St. Francis Cancer Center at St. Francis Medical Center
-
Waconia, Minnesota, 미국, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, 미국, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Missouri
-
Saint Louis, Missouri, 미국, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, 미국, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
-
Springfield, Missouri, 미국, 65802
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, 미국, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, 미국, 65807
- Hulston Cancer Center at Cox Medical Center South
-
-
Montana
-
Billings, Montana, 미국, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, 미국, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, 미국, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, 미국, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, 미국, 59107-7000
- Billings Clinic - Downtown
-
Bozeman, Montana, 미국, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, 미국, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, 미국, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, 미국, 59405
-
Havre, Montana, 미국, 59501
- Northern Montana Hospital
-
Helena, Montana, 미국, 59601
- St. Peter's Hospital
-
Kalispell, Montana, 미국, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, 미국, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, 미국, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, 미국, 59801
- Community Medical Center
-
Missoula, Montana, 미국, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, 미국, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, 미국, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
-
Lincoln, Nebraska, 미국, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, 미국, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, 미국, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, 미국, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, 미국, 68131-2197
- Creighton University Medical Center
-
-
North Carolina
-
Rutherfordton, North Carolina, 미국, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, 미국, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, 미국, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, 미국, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, 미국, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, 미국, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, 미국, 58122
- MeritCare Broadway
-
Grand Forks, North Dakota, 미국, 58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Bellefontaine, Ohio, 미국, 43311
- Mary Rutan Hospital
-
Bowling Green, Ohio, 미국, 43402
- Wood County Oncology Center
-
Chillicothe, Ohio, 미국, 45601
- Adena Regional Medical Center
-
Clyde, Ohio, 미국, 43410
- North Coast Cancer Care - Clyde
-
Columbus, Ohio, 미국, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, 미국, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, 미국, 43215
- CCOP - Columbus
-
Columbus, Ohio, 미국, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, 미국, 43228
- Doctors Hospital at Ohio Health
-
Dayton, Ohio, 미국, 45405
- Grandview Hospital
-
Dayton, Ohio, 미국, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, 미국, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, 미국, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, 미국, 45420
- CCOP - Dayton
-
Delaware, Ohio, 미국, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, 미국, 44035
- Hematology Oncology Center
-
Findlay, Ohio, 미국, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, 미국, 45005-1066
- Middletown Regional Hospital
-
Greenville, Ohio, 미국, 45331
- Wayne Hospital
-
Kettering, Ohio, 미국, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, 미국, 43130
- Fairfield Medical Center
-
Lima, Ohio, 미국, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, 미국, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, 미국, 43537
- St. Luke's Hospital
-
Maumee, Ohio, 미국, 43537-1839
- Northwest Ohio Oncology Center
-
Newark, Ohio, 미국, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, 미국, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, 미국, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, 미국, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, 미국, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, 미국, 45504
- Mercy Medical Center
-
Sylvania, Ohio, 미국, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, 미국, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, 미국, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, 미국, 43606
- Toledo Hospital
-
Toledo, Ohio, 미국, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, 미국, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, 미국, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, 미국, 43623
- St. Anne Mercy Hospital
-
Troy, Ohio, 미국, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, 미국, 43567
- Fulton County Health Center
-
Westerville, Ohio, 미국, 43081
- Mount Carmel St. Ann's Cancer Center
-
Wilmington, Ohio, 미국, 45177
- Clinton Memorial Hospital
-
Xenia, Ohio, 미국, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Zanesville, Ohio, 미국, 43701
- Genesis - Good Samaritan Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, 미국, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, 미국, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, 미국, 18201
- Geisinger Hazleton Cancer Center
-
State College, Pennsylvania, 미국, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, 미국, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, 미국, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, 미국, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, 미국, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, 미국, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, 미국, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, 미국, 22401
- Fredericksburg Oncology, Incorporated
-
-
Wisconsin
-
Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, 미국, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, 미국, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, 미국, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Marinette, Wisconsin, 미국, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls, Wisconsin, 미국, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sturgeon Bay, Wisconsin, 미국, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
-
Wyoming
-
Casper, Wyoming, 미국, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, 미국, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free Survival at 6 Months
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 8월 1일
기본 완료 (실제)
2010년 7월 1일
연구 완료 (실제)
2012년 11월 1일
연구 등록 날짜
최초 제출
2008년 2월 28일
QC 기준을 충족하는 최초 제출
2008년 2월 28일
처음 게시됨 (추정)
2008년 2월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 5월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 30일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCCTG-N0775
- NCI-2009-00667 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
- CDR0000587708 (레지스트리 식별자: PDQ (Physician Data Query))
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .