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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
95
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alaska
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Anchorage, Alaska, Förenta staterna, 99508
- Providence Cancer Center
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Förenta staterna, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Förenta staterna, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Förenta staterna, 80210
- Porter Adventist Hospital
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Denver, Colorado, Förenta staterna, 80220
- Rose Medical Center
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Denver, Colorado, Förenta staterna, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Förenta staterna, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Förenta staterna, 80218
- St. Joseph Hospital
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Denver, Colorado, Förenta staterna, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Förenta staterna, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Förenta staterna, 80528
- Front Range Cancer Specialists
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Grand Junction, Colorado, Förenta staterna, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Förenta staterna, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Förenta staterna, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Förenta staterna, 80539
- McKee Medical Center
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Pueblo, Colorado, Förenta staterna, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Förenta staterna, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Förenta staterna, 80033
- Exempla Lutheran Medical Center
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Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Bloomington, Illinois, Förenta staterna, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Förenta staterna, 61701
- St. Joseph Medical Center
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Förenta staterna, 61520
- Graham Hospital
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Förenta staterna, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Förenta staterna, 62644
- Mason District Hospital
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Havana, Illinois, Förenta staterna, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Förenta staterna, 61455
- Mcdonough District Hospital
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Moline, Illinois, Förenta staterna, 61265
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Moline, Illinois, Förenta staterna, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Förenta staterna, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Förenta staterna, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Förenta staterna, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Förenta staterna, 61761
- Community Cancer Center
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Normal, Illinois, Förenta staterna, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Förenta staterna, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Förenta staterna, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Förenta staterna, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Förenta staterna, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61614
- Proctor Hospital
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Peoria, Illinois, Förenta staterna, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Förenta staterna, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Förenta staterna, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Förenta staterna, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Förenta staterna, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Förenta staterna, 61362
- Illinois CancerCare - Spring Valley
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Spring Valley, Illinois, Förenta staterna, 61362
- St. Margaret's Hospital
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Förenta staterna, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Förenta staterna, 46904
- Howard Community Hospital
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La Porte, Indiana, Förenta staterna, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Förenta staterna, 47374
- Reid Hospital & Health Care Services
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South Bend, Indiana, Förenta staterna, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Förenta staterna, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Förenta staterna, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Förenta staterna, 46617
- South Bend Clinic
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Förenta staterna, 52722
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Förenta staterna, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Förenta staterna, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Förenta staterna, 50307
- Mercy Capitol Hospital
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Mason City, Iowa, Förenta staterna, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Förenta staterna, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Förenta staterna, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Anthony, Kansas, Förenta staterna, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Förenta staterna, 67901
- Southwest Medical Center
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- CCOP - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Förenta staterna, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Förenta staterna, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Förenta staterna, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Förenta staterna, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Förenta staterna, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Förenta staterna, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Förenta staterna, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Förenta staterna, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Förenta staterna, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Förenta staterna, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Förenta staterna, 49201
- Foote Memorial Hospital
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Lambertville, Michigan, Förenta staterna, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Förenta staterna, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Förenta staterna, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Förenta staterna, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital - Monroe
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Muskegon, Michigan, Förenta staterna, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Förenta staterna, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Förenta staterna, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Förenta staterna, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Förenta staterna, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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Warren, Michigan, Förenta staterna, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Förenta staterna, 49519
- Metro Health Hospital
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Minnesota
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Alexandria, Minnesota, Förenta staterna, 56308
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Bemidji, Minnesota, Förenta staterna, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
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Duluth, Minnesota, Förenta staterna, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Förenta staterna, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Förenta staterna, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Förenta staterna, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Förenta staterna, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Förenta staterna, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Förenta staterna, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Förenta staterna, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Förenta staterna, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
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Springfield, Missouri, Förenta staterna, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Förenta staterna, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Förenta staterna, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Förenta staterna, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Förenta staterna, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Förenta staterna, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Förenta staterna, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Förenta staterna, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Förenta staterna, 59405
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Havre, Montana, Förenta staterna, 59501
- Northern Montana Hospital
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Helena, Montana, Förenta staterna, 59601
- St. Peter's Hospital
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Förenta staterna, 59801
- Community Medical Center
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Missoula, Montana, Förenta staterna, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Förenta staterna, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Förenta staterna, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Förenta staterna, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Förenta staterna, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Förenta staterna, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Förenta staterna, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Förenta staterna, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Förenta staterna, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Förenta staterna, 58122
- MeritCare Broadway
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Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bellefontaine, Ohio, Förenta staterna, 43311
- Mary Rutan Hospital
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Bowling Green, Ohio, Förenta staterna, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Förenta staterna, 45601
- Adena Regional Medical Center
-
Clyde, Ohio, Förenta staterna, 43410
- North Coast Cancer Care - Clyde
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Columbus, Ohio, Förenta staterna, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Förenta staterna, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Förenta staterna, 43215
- CCOP - Columbus
-
Columbus, Ohio, Förenta staterna, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Förenta staterna, 43228
- Doctors Hospital at Ohio Health
-
Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
-
Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Förenta staterna, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Förenta staterna, 45420
- CCOP - Dayton
-
Delaware, Ohio, Förenta staterna, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, Förenta staterna, 44035
- Hematology Oncology Center
-
Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, Förenta staterna, 45005-1066
- Middletown Regional Hospital
-
Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
-
Kettering, Ohio, Förenta staterna, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Förenta staterna, 43130
- Fairfield Medical Center
-
Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Förenta staterna, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Förenta staterna, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Förenta staterna, 43537-1839
- Northwest Ohio Oncology Center
-
Newark, Ohio, Förenta staterna, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Förenta staterna, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Förenta staterna, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Förenta staterna, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Förenta staterna, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Förenta staterna, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Förenta staterna, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Förenta staterna, 43606
- Toledo Hospital
-
Toledo, Ohio, Förenta staterna, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Förenta staterna, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Förenta staterna, 43623
- St. Anne Mercy Hospital
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Troy, Ohio, Förenta staterna, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
-
Westerville, Ohio, Förenta staterna, 43081
- Mount Carmel St. Ann's Cancer Center
-
Wilmington, Ohio, Förenta staterna, 45177
- Clinton Memorial Hospital
-
Xenia, Ohio, Förenta staterna, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Zanesville, Ohio, Förenta staterna, 43701
- Genesis - Good Samaritan Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Förenta staterna, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Förenta staterna, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Förenta staterna, 18201
- Geisinger Hazleton Cancer Center
-
State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Förenta staterna, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, Förenta staterna, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Förenta staterna, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Förenta staterna, 22401
- Fredericksburg Oncology, Incorporated
-
-
Wisconsin
-
Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Förenta staterna, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Förenta staterna, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Marinette, Wisconsin, Förenta staterna, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
-
Wyoming
-
Casper, Wyoming, Förenta staterna, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free Survival at 6 Months
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2008
Primärt slutförande (Faktisk)
1 juli 2010
Avslutad studie (Faktisk)
1 november 2012
Studieregistreringsdatum
Först inskickad
28 februari 2008
Först inskickad som uppfyllde QC-kriterierna
28 februari 2008
Första postat (Uppskatta)
29 februari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neuroendokrina tumörer
- Nevi och melanom
- Melanom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Antineoplastiska medel, fytogena
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Karboplatin
- Paklitaxel
- Temozolomid
- Bevacizumab
- Albuminbundet paklitaxel
Andra studie-ID-nummer
- NCCTG-N0775
- NCI-2009-00667 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000587708 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .