Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
1. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
48
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Cancer Center
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259-5499
- Mayo Clinic Scottsdale
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Castro Valley, California, Forenede Stater, 94546
- Eden Medical Center
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Hayward, California, Forenede Stater, 94545
- Saint Rose Hospital
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Oakland, California, Forenede Stater, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Forenede Stater, 94602
- Highland General Hospital at St. George's University School of Medicine
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Pleasanton, California, Forenede Stater, 94588
- Valley Care Medical Center
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San Pablo, California, Forenede Stater, 94806
- Doctors Medical Center - San Pablo Campus
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Jacksonville
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Atlanta, Georgia, Forenede Stater, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Forenede Stater, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Forenede Stater, 30342
- CCOP - Atlanta Regional
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Austell, Georgia, Forenede Stater, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Forenede Stater, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, Forenede Stater, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Forenede Stater, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Forenede Stater, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, Forenede Stater, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Forenede Stater, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Illinois
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Alton, Illinois, Forenede Stater, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Forenede Stater, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Forenede Stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital
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Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
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Eureka, Illinois, Forenede Stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic
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Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
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Hopedale, Illinois, Forenede Stater, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Mt. Vernon, Illinois, Forenede Stater, 62864
- Good Samaritan Regional Health Center
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
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Ottawa, Illinois, Forenede Stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forenede Stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forenede Stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forenede Stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Forenede Stater, 61362
- St. Margaret's Hospital
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Forenede Stater, 47374
- Reid Hospital & Health Care Services, Incorporated
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic, PC
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Cedar Rapids Oncology Associates
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Davenport, Iowa, Forenede Stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Forenede Stater, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Forenede Stater, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Forenede Stater, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Forenede Stater, 67901
- Southwest Medical Center
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, Forenede Stater, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Forenede Stater, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas, PA - Winfield
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Forenede Stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Forenede Stater, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Forenede Stater, 49201
- Foote Hospital
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Lansing, Michigan, Forenede Stater, 48909
- Sparrow Regional Cancer Center
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Mount Clemens, Michigan, Forenede Stater, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
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Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute - Saginaw
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Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Forenede Stater, 56308
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Bemidji, Minnesota, Forenede Stater, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Forenede Stater, 56537
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Forenede Stater, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Forenede Stater, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Forenede Stater, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Cancer Center
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St Paul, Minnesota, Forenede Stater, 55102
- St. Joseph's Hospital
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St. Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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St. Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Forenede Stater, 55125
- Woodwinds Health Campus
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Pascagoula, Mississippi, Forenede Stater, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63701
- Saint Francis Medical Center
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Gape Girardeau, Missouri, Forenede Stater, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, Forenede Stater, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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Springfield, Missouri, Forenede Stater, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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St. Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Cancer Center
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St. Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Forenede Stater, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forenede Stater, 59101
- St. Vincent Healthcare
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Billings, Montana, Forenede Stater, 59107-5100
- Billings Clinic Cancer Center
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Billings, Montana, Forenede Stater, 59107-7000
- Deaconess Billings Clinic - Downtown
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Hospital
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Butte, Montana, Forenede Stater, 59701
- St. James Community Hospital
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Great Falls, Montana, Forenede Stater, 59405
- Big Sky Oncology
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Great Falls, Montana, Forenede Stater, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Helena, Montana, Forenede Stater, 59601
- St. Peter's Hospital
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Forenede Stater, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Forenede Stater, 59801
- Community Medical Center
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Missoula, Montana, Forenede Stater, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Forenede Stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Forenede Stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, Forenede Stater, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Lincoln, Nebraska, Forenede Stater, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
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New York
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Glens Falls, New York, Forenede Stater, 12801
- Adirondack Cancer Care - Glens Falls
-
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North Carolina
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Asheboro, North Carolina, Forenede Stater, 27203-5400
- Randolph Hospital
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
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Greensboro, North Carolina, Forenede Stater, 27403-1198
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
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Hendersonville, North Carolina, Forenede Stater, 28791
- Pardee Memorial Hospital
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Reidsville, North Carolina, Forenede Stater, 27320
- Annie Penn Cancer Center
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Rutherfordton, North Carolina, Forenede Stater, 28139
- Rutherford Hospital
-
Statesville, North Carolina, Forenede Stater, 28677
- Iredell Memorial Hospital
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Forenede Stater, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, Forenede Stater, 58502
- St. Alexius Medical Center
-
Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forenede Stater, 58122
- MeritCare Medical Group
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Grand Forks, North Dakota, Forenede Stater, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
-
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, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Forenede Stater, 43215
- Grant Riverside Cancer Services
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
-
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, 45429
- CCOP - Dayton
-
Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Medical Associates
-
Kettering, Ohio, Forenede Stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
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Marietta, Ohio, Forenede Stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Middletown, Ohio, Forenede Stater, 45044
- Middletown Regional Hospital
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Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, Forenede Stater, 45504
- Mercy Medical Center
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Troy, Ohio, Forenede Stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Westerville, Ohio, Forenede Stater, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
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Wright-Patterson Afb, Ohio, Forenede Stater, 45433-5529
- United States Air Force Medical Center - Wright-Patterson
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Xenia, Ohio, Forenede Stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Zanesville, Ohio, Forenede Stater, 43701
- Genesis - Good Samaritan Hospital
-
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
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Oregon
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Gresham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
-
Milwaukie, Oregon, Forenede Stater, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Forenede Stater, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Forenede Stater, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
-
Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
-
Salem, Oregon, Forenede Stater, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Sayre, Pennsylvania, Forenede Stater, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
-
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South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- AnMed Health Cancer Center
-
Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center, PC
-
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
-
-
Texas
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Houston, Texas, Forenede Stater, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
-
Virginia
-
Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
-
-
Washington
-
Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Forenede Stater, 98310
- Olympic Hematology and Oncology
-
Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Forenede Stater, 98112
- Group Health Central Hospital
-
Seattle, Washington, Forenede Stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Forenede Stater, 98122
- Polyclinic First Hill
-
Seattle, Washington, Forenede Stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest - Spokane South
-
Vancouver, Washington, Forenede Stater, 98668
- Southwest Washington Medical Center Cancer Center
-
Wenatchee, Washington, Forenede Stater, 98801-2028
- Wenatchee Valley Medical Center
-
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Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- 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
-
Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Franciscan Skemp Healthcare
-
Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wyoming
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Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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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
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
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Proportion of progression-free patients at 3 months
Tidsramme: at 3 months
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at 3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Progressionsfri overlevelse
Tidsramme: Op til 5 år
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Op til 5 år
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Samlet overlevelse
Tidsramme: Op til 5 år
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Op til 5 år
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Varighed af svar
Tidsramme: Op til 5 år
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Op til 5 år
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Tid til behandlingssvigt
Tidsramme: Op til 5 år
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Op til 5 år
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Response (complete and partial) as assessed by RECIST criteria
Tidsramme: Up to 5 years
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Up to 5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute
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. maj 2006
Primær færdiggørelse (Faktiske)
1. maj 2007
Studieafslutning (Faktiske)
1. april 2010
Datoer for studieregistrering
Først indsendt
20. december 2005
Først indsendt, der opfyldte QC-kriterier
20. december 2005
Først opslået (Skøn)
22. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Folinsyreantagonister
- Bevacizumab
- Pemetrexed
Andre undersøgelses-id-numre
- NCCTG-N0426
- NCI-2012-02681 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- SWOG-N0426
- CDR0000456427 (Registry Identifier: PDQ (Physician Data Query))
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 .