- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00268489
Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer.
Secondary
- Determine the tumor response rate in these patients.
- Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients.
- Determine the toxicity profile of this drug regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
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Alaska
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Anchorage, Alaska, 미국, 99508
- Providence Cancer Center
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Arizona
-
Scottsdale, Arizona, 미국, 85259-5499
- Mayo Clinic Scottsdale
-
-
Arkansas
-
Little Rock, Arkansas, 미국, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
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California
-
Castro Valley, California, 미국, 94546
- Eden Medical Center
-
Hayward, California, 미국, 94545
- Saint Rose Hospital
-
Oakland, California, 미국, 94609
- Alta Bates Summit Medical Center - Summit Campus
-
Oakland, California, 미국, 94609
- CCOP - Bay Area Tumor Institute
-
Oakland, California, 미국, 94602
- Highland General Hospital at St. George's University School of Medicine
-
Pleasanton, California, 미국, 94588
- Valley Care Medical Center
-
San Pablo, California, 미국, 94806
- Doctors Medical Center - San Pablo Campus
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-
Florida
-
Jacksonville, Florida, 미국, 32224
- Mayo Clinic - Jacksonville
-
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Georgia
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Atlanta, Georgia, 미국, 30309
- Piedmont Hospital
-
Atlanta, Georgia, 미국, 30342-1611
- Northside Hospital Cancer Center
-
Atlanta, Georgia, 미국, 30342-1701
- Saint Joseph's Hospital of Atlanta
-
Atlanta, Georgia, 미국, 30342
- CCOP - Atlanta Regional
-
Austell, Georgia, 미국, 30106
- WellStar Cobb Hospital
-
Decatur, Georgia, 미국, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
-
Lawrenceville, Georgia, 미국, 30045
- Gwinnett Medical Center
-
Marietta, Georgia, 미국, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
-
Riverdale, Georgia, 미국, 30274-2600
- Southern Regional Medical Center
-
Savannah, Georgia, 미국, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
Valdosta, Georgia, 미국, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Illinois
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Alton, Illinois, 미국, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
-
Aurora, Illinois, 미국, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, 미국, 61701
- St. Joseph Medical Center
-
Canton, Illinois, 미국, 61520
- Graham Hospital
-
Carthage, Illinois, 미국, 62321
- Memorial Hospital
-
Eureka, Illinois, 미국, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, 미국, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, 미국, 61401
- Galesburg Clinic
-
Havana, Illinois, 미국, 62644
- Mason District Hospital
-
Hopedale, Illinois, 미국, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, 미국, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Macomb, Illinois, 미국, 61455
- Mcdonough District Hospital
-
Maywood, Illinois, 미국, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
Mt. Vernon, Illinois, 미국, 62864
- Good Samaritan Regional Health Center
-
Normal, Illinois, 미국, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, 미국, 61761
- 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
-
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 Valley Community Hospital
-
Princeton, Illinois, 미국, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, 미국, 61362
- St. Margaret's Hospital
-
Urbana, Illinois, 미국, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, 미국, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Michigan City, Indiana, 미국, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, 미국, 47374
- Reid Hospital & Health Care Services, Incorporated
-
-
Iowa
-
Ames, Iowa, 미국, 50010
- McFarland Clinic, PC
-
Cedar Rapids, Iowa, 미국, 52403
- Cedar Rapids Oncology Associates
-
Davenport, Iowa, 미국, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
-
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, 50307
- Mercy Capitol Hospital
-
Des Moines, Iowa, 미국, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran 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 Regional Cancer Center
-
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
-
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Kansas
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Chanute, Kansas, 미국, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, 미국, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, 미국, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Kingman, Kansas, 미국, 67068
- Cancer Center of Kansas, PA - Kingman
-
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
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Salina, Kansas, 미국, 67042
- Cancer Center of Kansas, PA - Salina
-
Salina, Kansas, 미국, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
-
Wellington, Kansas, 미국, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, 미국, 67203
- Associates in Womens Health, PA - North Review
-
Wichita, Kansas, 미국, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, 미국, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, 미국, 67214
- CCOP - Wichita
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Wichita, Kansas, 미국, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Winfield, Kansas, 미국, 67156
- Cancer Center of Kansas, PA - Winfield
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- Cancer Research Center at Boston Medical Center
-
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Michigan
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Ann Arbor, Michigan, 미국, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, 미국, 48106
- CCOP - Michigan Cancer Research Consortium
-
Dearborn, Michigan, 미국, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, 미국, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
-
Flint, Michigan, 미국, 48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain, Michigan, 미국, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, 미국, 49201
- Foote Hospital
-
Lansing, Michigan, 미국, 48909
- Sparrow Regional Cancer Center
-
Mount Clemens, Michigan, 미국, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
-
Saginaw, Michigan, 미국, 48601
- Seton Cancer Institute - Saginaw
-
Warren, Michigan, 미국, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, 미국, 56308
-
Bemidji, Minnesota, 미국, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, 미국, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, 미국, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, 미국, 55805
- CCOP - Duluth
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Duluth, Minnesota, 미국, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, 미국, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, 미국, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, 미국, 56537
-
Fridley, Minnesota, 미국, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, 미국, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, 미국, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, 미국, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, 미국, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, 미국, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, 미국, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, 미국, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, 미국, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, 미국, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, 미국, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, 미국, 55379
- Saint Francis Cancer Center
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St Paul, Minnesota, 미국, 55102
- St. Joseph's Hospital
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St. Cloud, Minnesota, 미국, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, 미국, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, 미국, 55102
- United Hospital
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St. Paul, Minnesota, 미국, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, 미국, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, 미국, 55125
- Woodwinds Health Campus
-
Woodbury, Minnesota, 미국, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Pascagoula, Mississippi, 미국, 39581
- Regional Cancer Center at Singing River Hospital
-
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Missouri
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Cape Girardeau, Missouri, 미국, 63701
- Saint Francis Medical Center
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Gape Girardeau, Missouri, 미국, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Kansas City, Missouri, 미국, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, 미국, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, 미국, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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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
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St. Louis, Missouri, 미국, 63131
- Missouri Baptist Cancer Center
-
St. Louis, Missouri, 미국, 63141
- CCOP - St. Louis-Cape Girardeau
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Montana
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Billings, Montana, 미국, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, 미국, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, 미국, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, 미국, 59101
- St. Vincent Healthcare
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Billings, Montana, 미국, 59107-5100
- Billings Clinic Cancer Center
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Billings, Montana, 미국, 59107-7000
- Deaconess Billings Clinic - Downtown
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Bozeman, Montana, 미국, 59715
- Bozeman Deaconess Hospital
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Butte, Montana, 미국, 59701
- St. James Community Hospital
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Great Falls, Montana, 미국, 59405
- Big Sky Oncology
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Great Falls, Montana, 미국, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Helena, Montana, 미국, 59601
- St. Peter's Hospital
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Kalispell, Montana, 미국, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, 미국, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, 미국, 59901
- Kalispell Medical Oncology
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Missoula, Montana, 미국, 59801
- Community Medical Center
-
Missoula, Montana, 미국, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, 미국, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, 미국, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
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Nebraska
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Kearney, Nebraska, 미국, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
-
Lincoln, Nebraska, 미국, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, 미국, 68106
- CCOP - Missouri Valley Cancer Consortium
-
-
New York
-
Glens Falls, New York, 미국, 12801
- Adirondack Cancer Care - Glens Falls
-
-
North Carolina
-
Asheboro, North Carolina, 미국, 27203-5400
- Randolph Hospital
-
Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital, Incorporated
-
Greensboro, North Carolina, 미국, 27403-1198
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
-
Hendersonville, North Carolina, 미국, 28791
- Pardee Memorial Hospital
-
Reidsville, North Carolina, 미국, 27320
- Annie Penn Cancer Center
-
Rutherfordton, North Carolina, 미국, 28139
- Rutherford Hospital
-
Statesville, North Carolina, 미국, 28677
- Iredell Memorial Hospital
-
-
North Dakota
-
Bismarck, North Dakota, 미국, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, 미국, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, 미국, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, 미국, 58502
- St. Alexius Medical Center
-
Fargo, North Dakota, 미국, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, 미국, 58122
- MeritCare Medical Group
-
Grand Forks, North Dakota, 미국, 58201
- Altru Cancer Center at Altru Hospital
-
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Ohio
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Chillicothe, Ohio, 미국, 45601
- Adena Regional Medical Center
-
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, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, 미국, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, 미국, 45428
- Veterans Affairs Medical Center - Dayton
-
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, 45429
- CCOP - Dayton
-
Delaware, Ohio, 미국, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, 미국, 45840
- Blanchard Valley Medical Associates
-
Kettering, Ohio, 미국, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, 미국, 43130
- Fairfield Medical Center
-
Marietta, Ohio, 미국, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Middletown, Ohio, 미국, 45044
- Middletown Regional Hospital
-
Newark, Ohio, 미국, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Springfield, Ohio, 미국, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, 미국, 45504
- Mercy Medical Center
-
Troy, Ohio, 미국, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Westerville, Ohio, 미국, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
-
Wright-Patterson Afb, Ohio, 미국, 45433-5529
- United States Air Force Medical Center - Wright-Patterson
-
Xenia, Ohio, 미국, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Zanesville, Ohio, 미국, 43701
- Genesis - Good Samaritan Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, 미국, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
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Gresham, Oregon, 미국, 97030
- Legacy Mount Hood Medical Center
-
Milwaukie, Oregon, 미국, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, 미국, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, 미국, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, 미국, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, 미국, 97210
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
-
Portland, Oregon, 미국, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
-
Salem, Oregon, 미국, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
Tualatin, Oregon, 미국, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, 미국, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Sayre, Pennsylvania, 미국, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
-
-
South Carolina
-
Anderson, South Carolina, 미국, 29621
- AnMed Health Cancer Center
-
Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
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
- Avera Cancer Institute
-
Sioux Falls, South Dakota, 미국, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, 미국, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Knoxville, Tennessee, 미국, 37916
- Thompson Cancer Survival Center
-
-
Texas
-
Houston, Texas, 미국, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
-
Virginia
-
Danville, Virginia, 미국, 24541
- Danville Regional Medical Center
-
-
Washington
-
Bellingham, Washington, 미국, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, 미국, 98310
- Olympic Hematology and Oncology
-
Seattle, Washington, 미국, 98104
- Harborview Medical Center
-
Seattle, Washington, 미국, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, 미국, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, 미국, 98112
- Group Health Central Hospital
-
Seattle, Washington, 미국, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, 미국, 98122
- Polyclinic First Hill
-
Seattle, Washington, 미국, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, 미국, 99202
- Cancer Care Northwest - Spokane South
-
Vancouver, Washington, 미국, 98668
- Southwest Washington Medical Center Cancer Center
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Wenatchee, Washington, 미국, 98801-2028
- Wenatchee Valley Medical Center
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Wisconsin
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Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, 미국, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, 미국, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Green Bay, Wisconsin, 미국, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
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La Crosse, Wisconsin, 미국, 54601
- Franciscan Skemp Healthcare
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Marinette, Wisconsin, 미국, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, 미국, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, 미국, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wyoming
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Sheridan, Wyoming, 미국, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer
Stage IIIB patients must have pleural effusion
- No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to drainage
- Mixed histology allowed if all components consistent with non-small cell lung cancer
- Tumors with squamous cell histology feature are allowed
Must have measurable disease with at least one lesion with a longest diameter accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT
Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels should receive palliative radiation
- The irradiated lesion should not be a target lesion
- Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or advanced disease setting
No symptomatic, untreated, or uncontrolled CNS metastases
- CNS metastases treated with prior whole brain radiotherapy allowed
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/ mm^3
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin normal
- AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
- Creatinine clearance ≥ 45 mL/min
- Urine protein:creatinine ratio < 1.0
- Pregnant or nursing women are ineligible
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No seizure disorder
- No clinically significant infection
- No other second primary malignancy within the past 5 years except carcinoma in situ of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6) localized prostate cancer
- No hypertension or labile hypertension
- No history of poor compliance with antihypertensive medications
- No angina pectoris
- No congestive heart failure within the past 3 months unless ejection fraction > 40%
- No myocardial infarction within the past 6 months
- No cardiac arrhythmia
- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
No active or recent history of hemoptysis
- Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is acceptable
- No diabetes
- No prior serious, non-healing wounds, ulcers, or bone fractures
- No history of stroke within the past 6 months
- No history of abdominal fistula or gastrointestinal perforation
- No intra-abdominal abscess within the past 6 months
- Not at greater than average risk of bleeding
- No significant traumatic injury within the past 4 weeks
PRIOR CONCURRENT THERAPY:
- No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after pemetrexed disodium treatment
- No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)
- No immunotherapy or biologic therapy within the past 2 weeks
No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks
- The site of previous radiotherapy should have evidence of progressive disease if it is the only site of disease
- No prior post pelvic radiation
- No prior use of pemetrexed disodium
- No prior radiation to > 25% of the marrow cavity
- No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks
- No minor surgery within the past 2 weeks except insertion of a vascular access device
- No concurrent major surgery
- No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational within the past 4 weeks
- No concurrent use of Hypericum perforatum (St. John's wort)
No concurrent anticoagulant use
- Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: pemetrexed + bevacizumab
Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Proportion of progression-free patients at 3 months
기간: at 3 months
|
at 3 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
무진행 생존
기간: 최대 5년
|
최대 5년
|
|
전반적인 생존
기간: 최대 5년
|
최대 5년
|
|
응답 기간
기간: 최대 5년
|
최대 5년
|
|
치료 실패까지의 시간
기간: 최대 5년
|
최대 5년
|
|
Response (complete and partial) as assessed by RECIST criteria
기간: Up to 5 years
|
Up to 5 years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCCTG-N0426
- NCI-2012-02681 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
- SWOG-N0426
- CDR0000456427 (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. .