Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery
30. april 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
OBJECTIVES:
Primary
- To assess the anti-tumor activity, in terms of the percentage of patients who are treated with these regimens and who are progression-free at 6 months.
- To assess the safety profile of each treatment regimen.
Secondary
- To estimate the response rate in patients treated with these regimens.
- To estimate the distribution of progression-free survival time and overall survival time of patients treated with these regimens.
Tertiary
- To examine the impact of therapy on angiogenesis and immune homeostasis.
OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1) and location of metastatic disease (M1a [skin or subcutaneous tissue or lymph node only] vs M1b [lung] vs M1c [other visceral sites]) and randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual 8/21/09)
- Arm II: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for VEGF plasma levels and analysis of changes in immune homeostasis.
Beginning at study entry, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.
Studietype
Intervensjonell
Registrering (Faktiske)
95
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alaska
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Anchorage, Alaska, Forente stater, 99508
- Providence Cancer Center
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Arizona
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Scottsdale, Arizona, Forente stater, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Forente stater, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Forente stater, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Forente stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forente stater, 80220
- Rose Medical Center
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Denver, Colorado, Forente stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forente stater, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Forente stater, 80218
- St. Joseph Hospital
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Denver, Colorado, Forente stater, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Forente stater, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Forente stater, 80528
- Front Range Cancer Specialists
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Grand Junction, Colorado, Forente stater, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Forente stater, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Forente stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forente stater, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Forente stater, 80539
- McKee Medical Center
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Pueblo, Colorado, Forente stater, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Forente stater, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Forente stater, 80033
- Exempla Lutheran Medical Center
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Bloomington, Illinois, Forente stater, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Forente stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forente stater, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Forente stater, 61520
- Graham Hospital
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Carthage, Illinois, Forente stater, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Forente stater, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Forente stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forente stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forente stater, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Forente stater, 62644
- Mason District Hospital
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Havana, Illinois, Forente stater, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Forente stater, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Forente stater, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Forente stater, 61455
- Mcdonough District Hospital
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Moline, Illinois, Forente stater, 61265
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Moline, Illinois, Forente stater, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Forente stater, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Forente stater, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Forente stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forente stater, 61761
- Community Cancer Center
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Normal, Illinois, Forente stater, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Forente stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forente stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forente stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Forente stater, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forente stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forente stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forente stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forente stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forente stater, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Forente stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forente stater, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Forente stater, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Forente stater, 61362
- Illinois CancerCare - Spring Valley
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Spring Valley, Illinois, Forente stater, 61362
- St. Margaret's Hospital
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Indiana
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Beech Grove, Indiana, Forente stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Forente stater, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Forente stater, 46904
- Howard Community Hospital
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La Porte, Indiana, Forente stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Forente stater, 47374
- Reid Hospital & Health Care Services
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South Bend, Indiana, Forente stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forente stater, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Forente stater, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Forente stater, 46617
- South Bend Clinic
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Iowa
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Ames, Iowa, Forente stater, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Forente stater, 52722
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Cedar Rapids, Iowa, Forente stater, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Forente stater, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Forente stater, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Forente stater, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Forente stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forente stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Forente stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Forente stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forente stater, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Forente stater, 50307
- Mercy Capitol Hospital
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Mason City, Iowa, Forente stater, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Forente stater, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forente stater, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Forente stater, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Anthony, Kansas, Forente stater, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Forente stater, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Forente stater, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Forente stater, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Forente stater, 67901
- Southwest Medical Center
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Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Forente stater, 67214
- CCOP - Wichita
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Wichita, Kansas, Forente stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Forente stater, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Forente stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Forente stater, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Forente stater, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Forente stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Forente stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forente stater, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Forente stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forente stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forente stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Forente stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Forente stater, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Forente stater, 49201
- Foote Memorial Hospital
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Lambertville, Michigan, Forente stater, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Forente stater, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Forente stater, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Forente stater, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital - Monroe
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Muskegon, Michigan, Forente stater, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Forente stater, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Forente stater, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Forente stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Forente stater, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Forente stater, 49684
- Munson Medical Center
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Warren, Michigan, Forente stater, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Forente stater, 49519
- Metro Health Hospital
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Minnesota
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Alexandria, Minnesota, Forente stater, 56308
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Bemidji, Minnesota, Forente stater, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Forente stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forente stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forente stater, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Forente stater, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Forente stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forente stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Forente stater, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Forente stater, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Forente stater, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Forente stater, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Forente stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Forente stater, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Forente stater, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Forente stater, 55102
- United Hospital
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Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Forente stater, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Forente stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Missouri
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Saint Louis, Missouri, Forente stater, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Forente stater, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
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Springfield, Missouri, Forente stater, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forente stater, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Forente stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Forente stater, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Forente stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forente stater, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Forente stater, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Forente stater, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Forente stater, 59405
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Havre, Montana, Forente stater, 59501
- Northern Montana Hospital
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Helena, Montana, Forente stater, 59601
- St. Peter's Hospital
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Kalispell, Montana, Forente stater, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Forente stater, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Forente stater, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Forente stater, 59801
- Community Medical Center
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Missoula, Montana, Forente stater, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Forente stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Forente stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Forente stater, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Forente stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forente stater, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Forente stater, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Forente stater, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Forente stater, 28139
- Rutherford Hospital
-
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North Dakota
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Bismarck, North Dakota, Forente stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forente stater, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Forente stater, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Forente stater, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Forente stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forente stater, 58122
- MeritCare Broadway
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Grand Forks, North Dakota, Forente stater, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bellefontaine, Ohio, Forente stater, 43311
- Mary Rutan Hospital
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Bowling Green, Ohio, Forente stater, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Forente stater, 45601
- Adena Regional Medical Center
-
Clyde, Ohio, Forente stater, 43410
- North Coast Cancer Care - Clyde
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Columbus, Ohio, Forente stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Forente stater, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Forente stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forente stater, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Forente stater, 43228
- Doctors Hospital at Ohio Health
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Dayton, Ohio, Forente stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forente stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forente stater, 45420
- CCOP - Dayton
-
Delaware, Ohio, Forente stater, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, Forente stater, 44035
- Hematology Oncology Center
-
Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, Forente stater, 45005-1066
- Middletown Regional Hospital
-
Greenville, Ohio, Forente stater, 45331
- Wayne Hospital
-
Kettering, Ohio, Forente stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Forente stater, 43130
- Fairfield Medical Center
-
Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Forente stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Forente stater, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Forente stater, 43537-1839
- Northwest Ohio Oncology Center
-
Newark, Ohio, Forente stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, Forente stater, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Forente stater, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Forente stater, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Forente stater, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Forente stater, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Forente stater, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forente stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forente stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forente stater, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forente stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Forente stater, 43623
- St. Anne Mercy Hospital
-
Troy, Ohio, Forente stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
-
Westerville, Ohio, Forente stater, 43081
- Mount Carmel St. Ann's Cancer Center
-
Wilmington, Ohio, Forente stater, 45177
- Clinton Memorial Hospital
-
Xenia, Ohio, Forente stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Zanesville, Ohio, Forente stater, 43701
- Genesis - Good Samaritan Hospital
-
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Danville, Pennsylvania, Forente stater, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Forente stater, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Forente stater, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Forente stater, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
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South Carolina
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Anderson, South Carolina, Forente stater, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, Forente stater, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Forente 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, Forente stater, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forente stater, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Forente stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
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Fredericksburg, Virginia, Forente stater, 22401
- Fredericksburg Oncology, Incorporated
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-
Wisconsin
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Green Bay, Wisconsin, Forente stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forente stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forente stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Forente stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Marinette, Wisconsin, Forente stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, Forente stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, Forente stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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-
Wyoming
-
Casper, Wyoming, Forente stater, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Histologic confirmed diagnosis of malignant melanoma
- Stage IV disease
- Not amenable tosurgery
Measurable disease with at least one lesion whose longest diameter canbe measured as ≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT
- No disease that is measurable by physical examination only
- No brain metastases per MRI or CT
- No radiographically documented invasion of adjacent organs(duodenum, stomach, etc.) or tumor invading major blood vessels
- ECOG performance status 0-1
- Life expectancy ≥ 4 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL (transfusion allowed)
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)
- AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Urine protein:creatinine ratio < 1.0 at screening ORproteinuria < 2+ by urine dipstick or protein ≤ 1 g by 24-hour urine collection
- Negative serum pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Active infection requiring parenteral antibiotics
- Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or100 mm Hg diastolic) despite treatment
- NYHA class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Myocardial infarction or unstable angina within the past 6 months
- Clinically significant peripheral vascular disease
- Deep venous thrombosis or pulmonary embolus within the past year
- Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices)
- Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
- Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
- History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)
- Clinically significant stroke or TIA within the past 6 months
- Seizures not controlled with standardmedical therapy
- Peripheral neuropathy ≥ grade 2
- History of other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treatable with local resection only or carcinoma in situ of the cervix
- Significant traumatic injury within the past 4 weeks
- History of hypertensive crisis or hypertensive encephalopathy
- Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
- Known hypersensitivity to any of the components of bevacizumab
- Known to be HIV positive
- Current or known history of hepatitis
- Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed
- No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,VEGF-trap, anti-VEGFR Mab)
- No ongoing need for full-dose oral or parenteral anticoagulation
- No ongoing anti-platelet treatment other than low-dose aspirin(i.e., aspirin 81 mg daily)
- No other investigational agents within the past 4 weeks
- No major surgical procedure or open biopsy within the past 4 weeks
- No fine needle aspirations or core biopsies within the past 7 days
- No prior chemotherapy in the metastatic setting
- No prior treatment with sunitinib malate or sorafenib
- No prior treatment with any taxane-based chemotherapy
- Patients who have had > 25% of their functional bone marrow irradiated are not eligible for this trial
- No adjuvant radiation therapy within the past 4 weeks
- More than 2 weeks since prior and no concurrent palliative radiation therapy
- No concurrent major surgical procedure
- No concurrent participation in another clinical study for procedures or agents that treat the same primary study malignancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival at 6 Months
Tidsramme: at 6 months
|
The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate.
Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria.
Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.
|
at 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval
Tidsramme: Up to 5 years
|
A confirmed tumor response is defined to be a Complete Response or Partial Response noted > as the objective status on 2 consecutive evaluations at least 8 > weeks apart. The proportion of tumor responses will be > estimated by the number of confirmed tumor responses divided > by the total number of evaluable patients. > Complete Response (CR): Disappearance of all target lesions > Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. > Progression (PD): At least a 20% increase in the sum of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. > Stable Disease (SD): Neither sufficient shrinkage to Qualify for PR nor sufficient increase to Qualify for PD taking as reference the smallest sum LD. responses will be calculated assuming that the number of > confirmed tumor responses follows a binomial distribution. |
Up to 5 years
|
|
Overall Survival
Tidsramme: Up to 5 years
|
Overall survival time is defined as the time from registration to death due to any cause.
The distribution of survival time will be estimated using the method of Kaplan-Meier.
|
Up to 5 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2008
Primær fullføring (Faktiske)
1. juli 2010
Studiet fullført (Faktiske)
1. november 2012
Datoer for studieregistrering
Først innsendt
28. februar 2008
Først innsendt som oppfylte QC-kriteriene
28. februar 2008
Først lagt ut (Anslag)
29. februar 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nevroendokrine svulster
- Nevi og melanomer
- Melanom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Karboplatin
- Paklitaksel
- Temozolomid
- Bevacizumab
- Albuminbundet paklitaksel
Andre studie-ID-numre
- NCCTG-N0775
- NCI-2009-00667 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
- CDR0000587708 (Registeridentifikator: PDQ (Physician Data Query))
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .