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S0205 Gemcitabin m/ eller uden Cetuximab som førstelinjebehandling ved lokalt avanceret bugspytkirtelkræft

16. november 2015 opdateret af: Southwest Oncology Group

Et fase III randomiseret åbent studie, der sammenligner Gemcitabine Plus Cetuximab (IMC-C225) versus Gemcitabin som førstelinjebehandling af patienter med avanceret bugspytkirtelkræft

RATIONALE: Lægemidler, der bruges i kemoterapi, såsom gemcitabin, virker på forskellige måder for at stoppe tumorceller i at dele sig, så de holder op med at vokse eller dør. Monoklonale antistoffer, såsom cetuximab, kan lokalisere tumorceller og enten dræbe dem eller levere tumordræbende stoffer til dem uden at skade normale celler. Det vides endnu ikke, om gemcitabin er mere effektivt med eller uden cetuximab til behandling af bugspytkirtelkræft.

FORMÅL: Dette randomiserede fase III-studie studerer at give gemcitabin sammen med cetuximab for at se, hvor godt det virker sammenlignet med at give gemcitabin alene som førstelinjebehandling til behandling af patienter med lokalt fremskredent inoperabelt eller metastatisk adenokarcinom i bugspytkirtlen.

Studieoversigt

Status

Afsluttet

Betingelser

Kræft i bugspytkirtlen

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Sammenlign den samlede overlevelse af patienter med lokalt fremskreden inoperabel eller metastatisk adenocarcinom i bugspytkirtlen behandlet med gemcitabin og cetuximab vs gemcitabin alene.
Sammenlign tiden til behandlingssvigt hos patienter behandlet med disse regimer.
Estimer procentdelen af patienter med epidermal vækstfaktorreceptor (EGFR) tumorekspression hos patienter behandlet med disse regimer.
Sammenlign den samlede overlevelse af patienter i den EGFR-positive undergruppe behandlet med disse regimer.
Sammenlign toksiciteten af disse regimer hos disse patienter.
Sammenlign den samlede responsrate (bekræftet og ubekræftet fuldstændig og delvis respons) hos patienter med målbar sygdom behandlet med disse regimer.
Sammenlign patientrapporten om smerte og livskvalitet for patienter, der er behandlet med disse regimer.

OVERSIGT: Dette er et åbent, randomiseret, multicenter-studie. Patienterne er stratificeret efter sygdomsstatus (lokalt fremskreden inoperabel vs metastatisk), Zubrod ydeevnestatus (0 eller 1 vs 2) og tidligere pancreatektomi (ja vs nej). Patienterne randomiseres til 1 ud af 2 behandlingsarme.

Arm I: Patienterne får cetuximab IV over 1-2 timer på dag 1, 8, 15 og 22 og gemcitabin IV over 30 minutter på dag 1, 8, 15 og 22 for kursus 1 og dag 1, 8 og 15 for alle efterfølgende kurser.
Arm II: Patienter får gemcitabin som i arm I. I begge arme gentages kurser hver 4. uge i fravær af sygdomsprogression eller uacceptabel toksicitet.

Livskvalitet vurderes ved baseline, før hvert forløb og ved afslutning af studieterapi.

Patienterne følges hver 6. måned i 2 år og derefter årligt i 1 år.

PROJEKTERET TILSLUTNING: I alt 704 patienter (352 pr. behandlingsarm) vil blive akkumuleret til denne undersøgelse inden for 5 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

766

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V8
    - Nova Scotia Cancer Centre
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Royal Victoria Hospital of Barrie
  - Mississauga, Ontario, Canada, L5B 1B8
    - Trillium Health Centre - Mississauga Site
  - Toronto, Ontario, Canada, M6R 1B5
    - St. Joseph's Health Centre - Toronto
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
Forenede Stater
- Alabama
  - Mobile, Alabama, Forenede Stater, 36652-2144
    - Mobile Infirmary Medical Center
  - Opelika, Alabama, Forenede Stater, 36801-5452
    - East Alabama Medical Center
- Alaska
  - Anchorage, Alaska, Forenede Stater, 99508
    - Alaska Regional Hospital Cancer Center
  - Anchorage, Alaska, Forenede Stater, 99519-6604
    - Cancer Center at Providence Alaska Medical Center
- Arizona
  - Glendale, Arizona, Forenede Stater, 85306
    - Banner Thunderbird Medical Center
  - Phoenix, Arizona, Forenede Stater, 85006
    - Banner Good Samaritan Medical Center
  - Phoenix, Arizona, Forenede Stater, 85006
    - CCOP - Western Regional, Arizona
- Arkansas
  - Ft. Smith, Arkansas, Forenede Stater, 72903
    - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  - Springdale, Arkansas, Forenede Stater, 72764
    - Highlands Oncology Group - Springdale
- California
  - Berkeley, California, Forenede Stater, 94704
    - Alta Bates Comprehensive Cancer Center
  - Burlingame, California, Forenede Stater, 94010
    - Peninsula Medical Center
  - Concord, California, Forenede Stater, 94524-4110
    - Mount Diablo Regional Cancer Center
  - Duarte, California, Forenede Stater, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fresno, California, Forenede Stater, 93720
    - California Cancer Center - Woodward Park Office
  - Fullerton, California, Forenede Stater, 92835
    - Virginia K. Crosson Cancer Center at St. Jude Medical Center
  - Greenbrae, California, Forenede Stater, 94904
    - Sutter Health Western Division Cancer Research Group
  - Greenbrae, California, Forenede Stater, 94904
    - Marin Cancer Institute at Marin General Hospital
  - Hayward, California, Forenede Stater, 94545
    - Saint Rose Hospital
  - Loma Linda, California, Forenede Stater, 92354
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Oakland, California, Forenede Stater, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, Forenede Stater, 94609
    - Summit Medical Center
  - Oakland, California, Forenede Stater, 94602
    - Highland General Hospital at St. George's University School of Medicine
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  - Pleasanton, California, Forenede Stater, 94588
    - Valley Care Medical Center
  - Sacramento, California, Forenede Stater, 95819
    - Mercy General Hospital
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, Forenede Stater, 94118
    - California Pacific Medical Center - California Campus
  - San Pablo, California, Forenede Stater, 94806
    - J.C. Robinson, M.D. Regional Cancer Center
  - Vallejo, California, Forenede Stater, 94589
    - Sutter Solano Medical Center
  - Walnut Creek, California, Forenede Stater, 94598
    - John Muir/Mt. Diablo Comprehensive Cancer Center
  - Whittier, California, Forenede Stater, 90602
    - Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
- Colorado
  - Aurora, Colorado, Forenede Stater, 80045
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
  - Colorado Springs, Colorado, Forenede Stater, 80909
    - Memorial Hospital
  - Denver, Colorado, Forenede Stater, 80220
    - Veterans Affairs Medical Center - Denver
  - Fort Collins, Colorado, Forenede Stater, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, Forenede Stater, 80524
    - Front Range Cancer Specialists
  - Greeley, Colorado, Forenede Stater, 80631
    - North Colorado Medical Center
  - Loveland, Colorado, Forenede Stater, 80539
    - McKee Medical Center
  - Montrose, Colorado, Forenede Stater, 81401
    - Montrose Memorial Hospital Cancer Center
  - Wheat Ridge, Colorado, Forenede Stater, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Danbury, Connecticut, Forenede Stater, 06810
    - Praxair Cancer Center at Danbury Hospital
  - Stamford, Connecticut, Forenede Stater, 06904
    - Carl and Dorothy Bennett Cancer Center at Stamford Hospital
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20007
    - Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, Forenede Stater, 20016
    - Sibley Memorial Hospital
- Florida
  - Boca Raton, Florida, Forenede Stater, 33486
    - Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
  - Daytona Beach, Florida, Forenede Stater, 32115
    - Halifax Medical Center
  - Ft. Lauderdale, Florida, Forenede Stater, 33316
    - Broward General Medical Center Cancer Center
  - Gainesville, Florida, Forenede Stater, 32610-0232
    - University of Florida Shands Cancer Center
  - Orange Park, Florida, Forenede Stater, 32073
    - Florida Oncology Associates
  - Orlando, Florida, Forenede Stater, 32803-1273
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Pensacola, Florida, Forenede Stater, 32514
    - West Florida Cancer Institute at West Florida Hospital - Pensacola
- Georgia
  - Columbus, Georgia, Forenede Stater, 31904
    - John B. Amos Community Cancer Center
  - Gainesville, Georgia, Forenede Stater, 30501
    - Northeast Georgia Medical Center
  - Macon, Georgia, Forenede Stater, 31208
    - Medical Center of Central Georgia
  - Savannah, Georgia, Forenede Stater, 31403-3089
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Valdosta, Georgia, Forenede Stater, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Idaho
  - Boise, Idaho, Forenede Stater, 83712
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Alton, Illinois, Forenede Stater, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, Forenede Stater, 60507
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Forenede Stater, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Forenede Stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Memorial Hospital
  - Decatur, Illinois, Forenede Stater, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, Forenede Stater, 60120
    - Sherman Hospital
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Clinic
  - Galesburg, Illinois, Forenede Stater, 61401
    - Medical and Surgical Specialists, L L C
  - Galesburg, Illinois, Forenede Stater, 61401
    - InterCommunity Cancer Center of Western Illinois
  - Geneva, Illinois, Forenede Stater, 60134
    - Delnor Community Hospital - Geneva
  - Havana, Illinois, Forenede Stater, 62644
    - Mason District Hospital
  - Hinsdale, Illinois, Forenede Stater, 60521
    - Hinsdale Hematology Oncology Associates
  - Hopedale, Illinois, Forenede Stater, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Forenede Stater, 60435
    - Joliet Oncology Hematology Associates, Limited - West
  - Kewanee, Illinois, Forenede Stater, 61443
    - Kewanee Hospital
  - La Grange, Illinois, Forenede Stater, 60525
    - La Grange Memorial Hospital
  - Macomb, Illinois, Forenede Stater, 61455
    - Mcdonough District Hospital
  - Mt. Vernon, Illinois, Forenede Stater, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center
  - Olympia Fields, Illinois, Forenede Stater, 60461
    - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
  - Ottawa, Illinois, Forenede Stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forenede Stater, 61350
    - Oncology Hematology Associates of Central Illinois - Ottawa
  - Pekin, Illinois, Forenede Stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Forenede Stater, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forenede Stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forenede Stater, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Forenede Stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forenede Stater, 61615
    - Oncology/Hematology Associates of Central Illinois, P.C.
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Forenede Stater, 61362
    - St. Margaret's Hospital
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Valley Cancer Center
  - Springfield, Illinois, Forenede Stater, 62781
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, Forenede Stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Forenede Stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Fort Wayne, Indiana, Forenede Stater, 46815
    - Fort Wayne Medical Oncology and Hematology
  - Michigan City, Indiana, Forenede Stater, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Forenede Stater, 47374
    - Reid Hospital & Health Care Services, Incorporated
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic, P. C.
  - Bettendorf, Iowa, Forenede Stater, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, Forenede Stater, 52402
    - St. Luke's Hospital
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Council Bluffs, Iowa, Forenede Stater, 51503
    - Heartland Oncology & Hematology
  - Davenport, Iowa, Forenede Stater, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, Forenede Stater, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Ottumwa, Iowa, Forenede Stater, 52501
    - Ottumwa Regional Health Center Cancer Center
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
  - Waterloo, Iowa, Forenede Stater, 50702
    - Covenant Cancer Treatment Center
  - Waterloo, Iowa, Forenede Stater, 50702
    - Cedar Valley Medical Specialists, P.C. - West Ridgeway Avenue
- Kansas
  - Chanute, Kansas, Forenede Stater, 66720
    - Cancer Center of Kansas, P.A. - Chanute
  - Dodge City, Kansas, Forenede Stater, 67801
    - Cancer Center of Kansas, P.A. - Dodge City
  - El Dorado, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, P.A. - El Dorado
  - Kansas City, Kansas, Forenede Stater, 66160-7357
    - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  - Kingman, Kansas, Forenede Stater, 67068
    - Cancer Center of Kansas, P.A. - Kingman
  - Liberal, Kansas, Forenede Stater, 67901
    - Southwest Medical Center
  - Newton, Kansas, Forenede Stater, 67114
    - Cancer Center of Kansas, P.A. - Newton
  - Parsons, Kansas, Forenede Stater, 67357
    - Cancer Center of Kansas, P.A. - Parsons
  - Pittsburg, Kansas, Forenede Stater, 66762
    - Mount Carmel Regional Cancer Center
  - Pratt, Kansas, Forenede Stater, 67124
    - Cancer Center of Kansas, P.A. - Pratt
  - Salina, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, P.A. - Salina
  - Topeka, Kansas, Forenede Stater, 66606
    - St. Francis Comprehensive Cancer Center
  - Topeka, Kansas, Forenede Stater, 66604
    - Stormont-Vail Cancer Center
  - Wellington, Kansas, Forenede Stater, 67152
    - Cancer Center of Kansas, P.A. - Wellington
  - Wichita, Kansas, Forenede Stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas, P.A. - Wichita
  - Wichita, Kansas, Forenede Stater, 67203
    - Associates in Womens Health, P.A. - North Review
  - Wichita, Kansas, Forenede Stater, 67208
    - Cancer Center of Kansas, P.A. - Medical Arts Tower
  - Winfield, Kansas, Forenede Stater, 67156
    - Cancer Center of Kansas, P.A. - Winfield
- Kentucky
  - Ashland, Kentucky, Forenede Stater, 41101
    - Cancer Care at Our Lady of Bellefonte Hospital
  - Lexington, Kentucky, Forenede Stater, 40503-9985
    - Central Baptist Hospital
- Louisiana
  - Shreveport, Louisiana, Forenede Stater, 71101
    - Cancer Treatment Center at Christus Schumpert St. Mary Place
- Maine
  - Lewiston, Maine, Forenede Stater, 04240
    - Central Maine Medical Center
  - Portland, Maine, Forenede Stater, 04101
    - Mercy Hospital
- Massachusetts
  - Attleboro, Massachusetts, Forenede Stater, 02703
    - Sturdy Memorial Hospital
  - Boston, Massachusetts, Forenede Stater, 02118
    - Cancer Research Center at Boston Medical Center
  - Boston, Massachusetts, Forenede Stater, 02135-2997
    - Caritas St. Elizabeth's Medical Center
  - Boston, Massachusetts, Forenede Stater, 02120
    - Cancer Center of Boston - Chestnut Hill
  - Methuen, Massachusetts, Forenede Stater, 01844
    - Caritas Holy Family Hospital
  - Norwood, Massachusetts, Forenede Stater, 02062
    - Caritas Norwood Hospital
- Michigan
  - Adrian, Michigan, Forenede Stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, Forenede Stater, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Battle Creek, Michigan, Forenede Stater, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, Forenede Stater, 49307
    - Mecosta County Medical Center
  - Detroit, Michigan, Forenede Stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Lacks Cancer Center at Saint Mary's Mercy Medical Center
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Spectrum Health Cancer Care - Butterworth Campus
  - Grand Rapids, Michigan, Forenede Stater, 49506
    - Metropolitan Hospital
  - Holland, Michigan, Forenede Stater, 49423
    - Holland Community Hospital
  - Kalamazoo, Michigan, Forenede Stater, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, Forenede Stater, 49007-3731
    - West Michigan Cancer Center
  - Kalamazooaa, Michigan, Forenede Stater, 49001
    - Borgess Medical Center
  - Lambertville, Michigan, Forenede Stater, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, P.C.
  - Marquette, Michigan, Forenede Stater, 49855
    - Upper Michigan Cancer Center at Marquette General Hospital
  - Midland, Michigan, Forenede Stater, 48670
    - MidMichigan Medical Center - Midland
  - Monroe, Michigan, Forenede Stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forenede Stater, 48162
    - Mercy Memorial Hospital System
  - Muskegon, Michigan, Forenede Stater, 49443
    - Hackley Hospital
  - Petoskey, Michigan, Forenede Stater, 49770
    - Northern Michigan Hospital
  - Pontiac, Michigan, Forenede Stater, 48341-2985
    - St. Joseph Mercy Hospital
  - Royal Oak, Michigan, Forenede Stater, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Traverse City, Michigan, Forenede Stater, 49684
    - Munson Medical Center
- Minnesota
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forenede Stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Forenede Stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  - Robbinsdale, Minnesota, Forenede Stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
  - St. Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Health Services
  - St. Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 39216-4505
    - University of Mississippi Medical Center
  - Kessler AFB, Mississippi, Forenede Stater, 39534
    - Keesler Medical Center - Keesler Air Force Base
- Missouri
  - Cape Girardeau, Missouri, Forenede Stater, 63701
    - Saint Francis Medical Center
  - Gape Girardeau, Missouri, Forenede Stater, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Springfield, Missouri, Forenede Stater, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forenede Stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forenede Stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - St. Louis, Missouri, Forenede Stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - St. Louis, Missouri, Forenede Stater, 63128
    - St. Anthony's Cancer Center
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forenede Stater, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Forenede Stater, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Forenede Stater, 59101
    - St. Vincent Healthcare
  - Billings, Montana, Forenede Stater, 59107-7000
    - Deaconess Billings Clinic - Downtown
  - Billings, Montana, Forenede Stater, 59107-5100
    - Deaconess Billings Clinic Cancer Center
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconess Hospital
  - Bozeman, Montana, Forenede Stater, 59715
    - Internal Medicine Associates of Bozeman
  - Butte, Montana, Forenede Stater, 59701
    - St. James Community Hospital
  - Great Falls, Montana, Forenede Stater, 59405
    - Big Sky Oncology
  - Great Falls, Montana, Forenede Stater, 59405
    - Sletten Regional Cancer Institute
  - Helena, Montana, Forenede Stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forenede Stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Medical Oncology
  - Miles City, Montana, Forenede Stater, 59301
    - Eastern Montana Cancer Center
  - Missoula, Montana, Forenede Stater, 59801
    - Community Medical Center
  - Missoula, Montana, Forenede Stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forenede Stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, Forenede Stater, 68848-1990
    - Good Samaritan Health Systems
  - Omaha, Nebraska, Forenede Stater, 68114
    - Methodist Cancer Center at Methodist Hospital - Omaha
- New Hampshire
  - Dover, New Hampshire, Forenede Stater, 03820
    - Seacoast Cancer Center at Wentworth-Douglass Hospital
- New Jersey
  - Ridgewood, New Jersey, Forenede Stater, 07450
    - Valley Hospital - Ridgewood
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87131-5636
    - University of New Mexico Cancer Research and Treatment Center
  - Farmington, New Mexico, Forenede Stater, 87401-5631
    - San Juan Regional Cancer Center
- New York
  - Albany, New York, Forenede Stater, 12208
    - New York Oncology Hematology, PC - Albany
  - Buffalo, New York, Forenede Stater, 14263-0001
    - Roswell Park Cancer Institute
  - Glens Falls, New York, Forenede Stater, 12801
    - Adirondack Cancer Care - Glens Falls
  - Latham, New York, Forenede Stater, 12110
    - New York Oncology Hematology, P.C.
  - Manhasset, New York, Forenede Stater, 11030
    - CCOP - North Shore University Hospital
  - New Hyde Park, New York, Forenede Stater, 11042
    - Long Island Jewish Medical Center
  - Syracuse, New York, Forenede Stater, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Syracuse, New York, Forenede Stater, 13203
    - St. Joseph's Hospital Health Center - Syracuse
  - Utica, New York, Forenede Stater, 13502
    - Faxton Regional Cancer Center
- North Carolina
  - Asheboro, North Carolina, Forenede Stater, 27203-5400
    - Randolph Hospital
  - Asheville, North Carolina, Forenede Stater, 28801
    - Mission Hospitals - Memorial Campus
  - Charlotte, North Carolina, Forenede Stater, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Eden, North Carolina, Forenede Stater, 27288
    - John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
  - Goldsboro, North Carolina, Forenede Stater, 27534
    - Wayne Radiation Oncology
  - Goldsboro, North Carolina, Forenede Stater, 27534
    - Wayne Memorial Hospital, Incorporated
  - Greensboro, North Carolina, Forenede Stater, 27403-1199
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Hendersonville, North Carolina, Forenede Stater, 28791
    - Pardee Memorial Hospital
  - Kinston, North Carolina, Forenede Stater, 28501
    - Lenoir Memorial Cancer Center
  - Reidsville, North Carolina, Forenede Stater, 27320
    - Annie Penn Cancer Center
  - Rutherfordton, North Carolina, Forenede Stater, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, Forenede Stater, 28677
    - Iredell Memorial Hospital
  - Wilson, North Carolina, Forenede Stater, 27893-3428
    - Wilson Medical Center
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Forsyth Regional Cancer Center at Forsyth Medical Center
- Ohio
  - Akron, Ohio, Forenede Stater, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Akron, Ohio, Forenede Stater, 44309-2090
    - Akron City Hospital
  - Bowling Green, Ohio, Forenede Stater, 43402
    - Wood County Oncology Center
  - Canton, Ohio, Forenede Stater, 44708
    - University Hospitals Ireland Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, Forenede Stater, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, Forenede Stater, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forenede Stater, 44112
    - Huron Hospital Cancer Care Center
  - Cleveland, Ohio, Forenede Stater, 44119
    - Euclid Hospital
  - Columbus, Ohio, Forenede Stater, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - 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
  - Columbus, Ohio, Forenede Stater, 43222
    - Mount Carmel West Hospital
  - 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, 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
  - Fremont, Ohio, Forenede Stater, 43420
    - Fremont Memorial Hospital
  - Independence, Ohio, Forenede Stater, 44131
    - Community Oncology Group at Cleveland Clinic Cancer Center
  - Kenton, Ohio, Forenede Stater, 43326
    - Kenton Oncology, Incorporated
  - Kettering, Ohio, Forenede Stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, Forenede Stater, 43130
    - Fairfield Medical Center
  - Lima, Ohio, Forenede Stater, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45801
    - St. Rita's Medical Center
  - Marietta, Ohio, Forenede Stater, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, Forenede Stater, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Forenede Stater, 43537
    - St. Luke's Hospital
  - Mayfield Heights, Ohio, Forenede Stater, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Middletown, Ohio, Forenede Stater, 45044
    - Middletown Regional Hospital
  - Newark, Ohio, Forenede Stater, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Forenede Stater, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, Forenede Stater, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, Forenede Stater, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, Forenede Stater, 45504
    - Mercy Medical Center
  - Sylvania, Ohio, Forenede Stater, 43560
    - Promedica Cancer Center at Flower Hospital
  - Toledo, Ohio, Forenede Stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forenede Stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forenede Stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, Forenede Stater, 43623
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forenede Stater, 43614
    - Medical College of Ohio Cancer Institute
  - Toledo, Ohio, Forenede Stater, 43623
    - Toledo Surgical Specialists
  - Troy, Ohio, Forenede Stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Warrensville Heights, Ohio, Forenede Stater, 44122
    - South Pointe Hospital Cancer Care Center
  - Wauseon, Ohio, Forenede Stater, 43567
    - Fulton County Health Center
  - Westerville, Ohio, Forenede Stater, 43081
    - Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  - Wooster, Ohio, Forenede Stater, 44691
    - Cleveland Clinic - Wooster
  - Wright-Patterson Afb, Ohio, Forenede Stater, 45433-5529
    - United States Air Force Medical Center Wright-Patterson
  - Xenia, Ohio, Forenede Stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Youngstown, Ohio, Forenede Stater, 44501
    - Tod Children's Hospital - Forum Health
  - Zanesville, Ohio, Forenede Stater, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Bend, Oregon, Forenede Stater, 97701
    - St. Charles Medical Center - Bend
  - 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, 97227
    - Institute of Oncology at Vilnius University
  - Portland, Oregon, Forenede Stater, 97210
    - Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  - Salem, Oregon, Forenede Stater, 97309-5014
    - Salem Hospital Regional Cancer Center
  - Tualatin, Oregon, Forenede Stater, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Bethlehem, Pennsylvania, Forenede Stater, 18015
    - St. Luke's Hospital Cancer Center
  - Dubois, Pennsylvania, Forenede Stater, 15801
    - Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center
  - Easton, Pennsylvania, Forenede Stater, 18042
    - Easton Regional Cancer Center at Easton Hospital
  - Langhorne, Pennsylvania, Forenede Stater, 19047
    - St. Mary Regional Cancer Center
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny Cancer Center at Allegheny General Hospital
  - Reading, Pennsylvania, Forenede Stater, 19612-6052
    - Reading Hospital and Medical Center
  - West Grove, Pennsylvania, Forenede Stater, 19390-9499
    - Jennersville Regional Hospital
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - Rose Ramer Cancer Clinic at Anderson Area Medical Center
  - Charleston, South Carolina, Forenede Stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston, South Carolina, Forenede Stater, 29401
    - Roper St. Francis Cancer Center at Roper Hospital
  - Florence, South Carolina, Forenede Stater, 29501
    - McLeod Regional Medical Center
  - Greenville, South Carolina, Forenede Stater, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, Forenede Stater, 29601
    - Bon Secours St. Francis Health System
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - 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
- Tennessee
  - Kingsport, Tennessee, Forenede Stater, 37662
    - Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  - Knoxville, Tennessee, Forenede Stater, 37916
    - Thompson Cancer Survival Center
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Harrington Cancer Center
  - Dallas, Texas, Forenede Stater, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, Forenede Stater, 75231
    - Presbyterian Hospital of Dallas
  - El Paso, Texas, Forenede Stater, 79902
    - Center for Cancer Medicine and Blood Disorders, PA
  - Fort Sam Houston, Texas, Forenede Stater, 78234
    - Brooke Army Medical Center
  - Houston, Texas, Forenede Stater, 77030
    - Baylor University Medical Center - Houston
  - Houston, Texas, Forenede Stater, 77030-4009
    - M.D. Anderson Cancer Center at University of Texas
  - Lackland AFB, Texas, Forenede Stater, 78236
    - Wilford Hall Medical Center
  - Lubbock, Texas, Forenede Stater, 79415-3364
    - UMC Southwest Cancer and Research Center
- Utah
  - American Fork, Utah, Forenede Stater, 84003
    - American Fork Hospital
  - Logan, Utah, Forenede Stater, 84321
    - Logan Regional Hospital
  - Murray, Utah, Forenede Stater, 84107
    - Cottonwood Hospital Medical Center
  - Ogden, Utah, Forenede Stater, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, Forenede Stater, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, Forenede Stater, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, Forenede Stater, 84143
    - LDS Hospital
  - Salt Lake City, Utah, Forenede Stater, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Bennington, Vermont, Forenede Stater, 05201
    - Green Mountain Oncology Group
  - Bennington, Vermont, Forenede Stater, 05201
    - Southwestern Vermont Regional Cancer Center
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22901
    - Martha Jefferson Hospital Cancer Care Center
  - Danville, Virginia, Forenede Stater, 24541
    - Danville Regional Medical Center
  - Norton, Virginia, Forenede Stater, 24273
    - Southwest Virginia Regional Cancer Center
- Washington
  - Auburn, Washington, Forenede Stater, 98002
    - Auburn Regional Center for Cancer Care
  - Bellingham, Washington, Forenede Stater, 98225
    - St. Joseph Hospital Community Cancer Center
  - Bremerton, Washington, Forenede Stater, 98310
    - Olympic Hematology and Oncology
  - Centralia, Washington, Forenede Stater, 98531-9027
    - Providence Centralia Hospital Regional Cancer Center
  - Federal Way, Washington, Forenede Stater, 98003
    - St. Francis Hospital
  - Mt. Vernon, Washington, Forenede Stater, 98273
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, Forenede Stater, 98507
    - Capital Medical Center
  - Olympia, Washington, Forenede Stater, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Puyallup, Washington, Forenede Stater, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, Forenede Stater, 98104
    - Harborview Medical Center
  - Seattle, Washington, Forenede Stater, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Forenede Stater, 98195-6043
    - University Cancer Center at University of Washington Medical Center
  - Seattle, Washington, Forenede Stater, 98104
    - Group Health Central Hospital
  - Seattle, Washington, Forenede Stater, 98114
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Sedro-Wooley, Washington, Forenede Stater, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, Forenede Stater, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, Forenede Stater, 99204-2967
    - Rockwood Clinic Cancer Treatment Center
  - Spokane, Washington, Forenede Stater, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - Spokane, Washington, Forenede Stater, 99207
    - Providence Cancer Center at Holy Family Hospital
  - Tacoma, Washington, Forenede Stater, 98405
    - Allenmore Hospital
  - Tacoma, Washington, Forenede Stater, 98405
    - CCOP - Northwest
  - Tacoma, Washington, Forenede Stater, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, Forenede Stater, 98499
    - St. Clare Hospital
  - Tacoma, Washington, Forenede Stater, 98405-3004
    - St. Joseph Medical Center at Franciscan Health System
  - Vancouver, Washington, Forenede Stater, 98668
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, Forenede Stater, 98801
    - Wenatchee Valley Clinic
- West Virginia
  - Clarksburg, West Virginia, Forenede Stater, 26301
    - United Hospital Center
  - Parkersburg, West Virginia, Forenede Stater, 26102
    - Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Wisconsin
  - Appleton, Wisconsin, Forenede Stater, 54911-3496
    - Fox Valley Hematology and Oncology - East Grant Street
  - Eau Claire, Wisconsin, Forenede Stater, 54703-1510
    - Midelfort Clinic - Luther
  - Eau Claire, Wisconsin, Forenede Stater, 54702
    - Luther Midlelfort Hospital
  - Elkhorn, Wisconsin, Forenede Stater, 53121
    - Vince Lombardi Cancer Center - Elkhorn
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - Medical Consultants, Limited
  - Racine, Wisconsin, Forenede Stater, 53405
    - All Saints Cancer Center at All Saints Medical Center
- Wyoming
  - Sheridan, Wyoming, Forenede Stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

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

SYGDOMS KARAKTERISTIKA:

Histologisk* eller cytologisk bekræftet pancreas adenokarcinom, der opfylder 1 af følgende kriterier:
- Lokalt fremskreden uoperabel sygdom
- Fjernmetastatisk sygdom BEMÆRK: Hvis diagnosen er baseret på et metastatisk sted, skal histologien være kompatibel med bugspytkirtelkræft
Målbar eller ikke-målbar sygdom ved røntgen, scanning eller fysisk undersøgelse
Tumorvæv skal indsendes til evaluering af epidermal vækstfaktor-receptorekspression før undersøgelsesstart
Ingen af følgende tumortyper er tilladt:
- Endokrine tumorer
- Lymfom i bugspytkirtlen
- Ampulær cancer
Ingen kendte hjernemetastaser

PATIENT KARAKTERISTIKA:

Alder

Ikke specificeret

Præstationsstatus

Zubrod 0-2

Forventede levealder

Mindst 3 måneder

Hæmatopoietisk

Absolut granulocyttal mindst 1.500/mm^3
Blodpladetal mindst 100.000/mm^3

Hepatisk

Bilirubin ikke større end 2,0 gange øvre normalgrænse (ULN)
SGOT eller SGPT ikke større end 2,5 gange ULN

Renal

Kreatinin ikke større end 2,0 mg/dL

Kardiovaskulær

Ingen signifikant historie med hjertesygdom
Ingen ukontrolleret hypertension
Ingen ustabil angina
Ingen ukontrolleret arytmi
Ingen kongestiv hjertesvigt

Andet

Ikke gravid eller ammende
Fertile patienter skal bruge effektiv prævention
HIV negativ
Ingen anden malignitet inden for de seneste 5 år bortset fra tilstrækkeligt behandlet basalcelle- eller pladecellehudkræft, carcinom in situ i livmoderhalsen eller tilstrækkeligt behandlet stadium I eller II kræft, som i øjeblikket er i remission

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi

Ingen forudgående immunterapi mod fremskreden kræft i bugspytkirtlen
Ingen tidligere cetuximab eller anden behandling, der retter sig mod epidermal vækstfaktorvej
Ingen tidligere kimæriseret eller murin monoklonal antistofterapi
Ingen anden samtidig anticancer immunterapi

Kemoterapi

Mindst 6 måneder siden tidligere adjuverende kemoterapi
Ingen forudgående kemoterapi eller kemoradioterapi til fremskreden kræft i bugspytkirtlen
Ingen tidligere gemcitabin
Ingen anden samtidig anticancer kemoterapi

Endokrin terapi

Ingen forudgående hormonbehandling for fremskreden bugspytkirtelkræft
Ingen samtidig anticancer hormonbehandling

Strålebehandling

Se Kemoterapi
Mindst 28 dage siden tidligere strålebehandling og restitueret
Forudgående palliativ strålebehandling til metastatiske steder tilladt
Ingen samtidig strålebehandling mod kræft, inklusive strålebehandling af hele hjernen for progressiv sygdom (dvs. CNS-metastaser)

Kirurgi

Mindst 14 dage siden tidligere bugspytkirtelkræftoperation og kommet sig

Andet

Ingen anden samtidig anticancerterapi

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: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: gemcitabinhydrochlorid + IMC-C225 Ladningsdosis: gemcitabinhydrochlorid 1000mg/m2, IV på dag 1; Cetuxiumab 400mg/m2, IV på dag 1 (kun cyklus 1) Ugentlig vedligeholdelse: Cetuximab 250mg/m2, IV på dag 8,15,22 i cyklus 1 & dag 1,8,15,22 i alle efterfølgende cyklusser; gemcitabinhydrochlorid 1000mg/m2, IV på dag 8,15,22 i cyklus 1 og dag 1,8,15 i alle efterfølgende cyklusser.	Biologisk: cetuximab Ladningsdosis: Cetuxiumab 400mg/m2, IV på dag 1 (kun cyklus 1). Ugentlig vedligeholdelse: Cetuximab 250mg/m2, IV på dag 8,15,22 i cyklus 1 og dag 1,8,15,22 i alle efterfølgende cyklusser Medicin: gemcitabin hydrochlorid 1000mg/m2 IV over 30 minutter
Eksperimentel: gemcitabinhydrochlorid alene gemcitabinhydrochlorid 1000mg/m2, IV på dag 1,8,15,22 i cyklus 1 og dag 1,8,15 i alle efterfølgende cyklusser.	Medicin: gemcitabin hydrochlorid 1000mg/m2 IV over 30 minutter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Samlet overlevelsessammenligning mellem behandlingsgrupper Tidsramme: hver 4. uge i 3 år	hver 4. uge i 3 år

Sekundære resultatmål

Resultatmål	Tidsramme
Sammenligning af responsrater mellem behandlingsgrupper målt ved RECIST og radiologisk evaluering ved hvert andet forløb Tidsramme: hver 9. uge indtil progression	hver 9. uge indtil progression
Tid til behandlingssvigt sammenligning mellem grupper fra registrering til første observation af progressiv sygdom, symptomatisk forværring eller død Tidsramme: hver 4. uge under behandling	hver 4. uge under behandling
Procentdel af patienter med EGFR-tumorekspression og sammenlign den samlede overlevelse af patienter i EGFR-undergruppen Tidsramme: hver 4. uge i 3 år	hver 4. uge i 3 år
Toksicitetsprofil sammenligning af patienter behandlet med 2 regimer og målt indtil 30 dage efter afslutning af undersøgelsesbehandling Tidsramme: hver 4. uge under behandling	hver 4. uge under behandling
Samlet responsrate sammenligning mellem behandlingsgrupper i undergruppen af patienter med målbar sygdom ved RECIST ved hvert andet forløb Tidsramme: hver 9. uge indtil progression	hver 9. uge indtil progression
Smerte og livskvalitet sammenligning mellem behandlingsgrupper målt ved patientspørgeskema ved baseline, før hvert forløb og derefter afslutning af undersøgelsesbehandling Tidsramme: hver 4. uge under behandling	hver 4. uge under behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Cancer and Leukemia Group B

Efterforskere

Studiestol: Philip A. Philip, MD, PhD, FRCP, Barbara Ann Karmanos Cancer Institute
Studiestol: Eileen O'Reilly, MD, Memorial Sloan Kettering Cancer Center
Studiestol: Ralph PW Wong, MD, FRCPC, CancerCare Manitoba

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.

Generelle publikationer

Philip PA, Benedetti J, Corless CL, Wong R, O'Reilly EM, Flynn PJ, Rowland KM, Atkins JN, Mirtsching BC, Rivkin SE, Khorana AA, Goldman B, Fenoglio-Preiser CM, Abbruzzese JL, Blanke CD. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. J Clin Oncol. 2010 Aug 1;28(22):3605-10. doi: 10.1200/JCO.2009.25.7550. Epub 2010 Jul 6.

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. januar 2004

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

9. januar 2004

Først indsendt, der opfyldte QC-kriterier

12. januar 2004

Først opslået (Skøn)

13. januar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000347414
U10CA032102 (U.S. NIH-bevilling/kontrakt)
S0205 (Anden identifikator: SWOG)
CALGB-S0205 (Anden identifikator: CALGB)
CAN-NCIC-PAC1 (Anden identifikator: NCIC-CTG)

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 .

Kliniske forsøg med Kræft i bugspytkirtlen

West China Hospital

Ikke rekrutterer endnu

En fase III, randomiseret, klinisk prøve af GnP kombineret med SBRT og Serplulimab versus GnP som førstelinjebehandling for patienter med tilbagevendende eller metastatisk bugspytkirtelkræft (WGOG-PAN 006/ICSBR-2)

PDAC - Pancreatic Ductal Adenocarcinoma
City of Hope Medical Center

Afsluttet

Exosomal miRNA væske-biopsi til tidlig opdagelse af levermetastaser ved bugspytkirtelkræft (FORESIGHT)

PDAC - Pancreatic Ductal Adenocarcinoma

Forenede Stater
Richard Hunger
Medizinische Hochschule Brandenburg Theodor Fontane

Afsluttet

Pancreaskirurgi - Optimale caseload-tærskler og prædiktiv nøjagtighed (PaSuT)

Volume-Outcome Relation i Pancreatic Surgery
Cedars-Sinai Medical Center

Suspenderet

Magnetisk resonansbilleddannelse (MRI) til at forudsige resultater af pancreas ductal adenocarcinom (PDAC)

PDAC - Pancreatic Ductal Adenocarcinoma

Forenede Stater
Massachusetts General Hospital
United States Department of Defense

Rekruttering

PDAC-Pathways: En digital informations- og understøttende pleje-app til patienter, der initierer neoadjuvant terapi til pancreasduktal adenocarcinom (PDAC-PATHWAYS)

PDAC - Pancreatic Ductal Adenocarcinoma

Forenede Stater
Tianjin Medical University Cancer Institute and...

Ikke rekrutterer endnu

Sitagliptin kombineret med gemcitabin og albuminbundet paclitaxel hos PDAC-patienter

PDAC - Pancreatic Ductal Adenocarcinoma
Sun Yat-sen University

Rekruttering

Nab-Paclitaxel og Gemcitabine Plus Camrelizumab og strålebehandling til lokalt avanceret bugspytkirteladenokarcinom

PDAC - Pancreatic Ductal Adenocarcinoma

Kina
Azienda Ospedaliera Universitaria Integrata Verona

Rekruttering

Cirkulerende tumor-DNA som kirurgisk biomarkør hos patienter med pancreatisk adenokarcinom til erklæring om resektabilitet (CASPER)

PDAC - Pancreatic Ductal Adenocarcinoma

Italien
Azienda Ospedaliera Universitaria Integrata Verona

Rekruttering

Prospektivt register over unge voksne patienter diagnosticeret med kræft i bugspytkirtlen (PanC-YOUNG)

PDAC - Pancreatic Ductal Adenocarcinoma

Italien
GERCOR - Multidisciplinary Oncology Cooperative...
Servier

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Panoramix: Optimering af 1.-linje Nalirifox og udforskning af Microbiotas rolle i 2. linie kræftbehandling i bugspytkirtlen (PANORAMIX)

PDAC - Pancreatic Ductal Adenocarcinoma

Frankrig

Kliniske forsøg med cetuximab

Amsterdam UMC, location VUmc
Radboud University Medical Center; University Medical Center Groningen

Afsluttet

Billedstyret behandlingsoptimering med Cetuximab til patienter med metastatisk tyktarmskræft (IMPACT-CRC)

Metastatisk tyktarmskræft

Holland
University Medical Center Groningen
UMC Utrecht; Erasmus Medical Center

Rekruttering

Billedstyret kirurgi til marginvurdering af hoved- og nakkekræft ved hjælp af Cetuximab-IRDye800CW conjugate (ICON)

Planocellulært karcinom i hoved og hals | Marginvurdering

Holland
Zhejiang University

Rekruttering

Sikkerhed og effekt af Cetuximab Beta plus Fruquintinib med eller uden immun checkpoint-hæmmere i første-linje behandling af RAS/BRAF wild type uoperabel metastatisk tyktarmskræft (concept)

Kolorektale neoplasmer | Fruquintinib | BRAF | RAS | Cetuximabβ

Kina
Meng Qiu

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Førstelinjebehandling af MCapOX + Cetuximab vs. MFOLFOX6 + Cetuximab til RAS/BRAF vildtype, MSS, uoperabel venstresidet MCRC: et multicenter, randomiseret, kontrolleret, fase III-studie (CAPCET-III)

Capecitabin | Kolorektal cancer (CRC) | Cetuximab

Kina
West China Hospital
First Affiliated Hospital of Chongqing Medical University

Rekruttering

Førstelinje mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab til metastatisk venstresidet CRC med vildtype RAS/BRAF-gener (CAPCET)

Colo-rektal cancer | Capecitabin | Cetuximab

Kina
Shanghai Ninth People's Hospital Affiliated to...

Rekruttering

Dalpicilib plus cetuximab sammenlignet med cetuximab alene i HPV-negativ, anti-PD-1-resistent R/M HNSCC

Tilbagevendende/metastatisk pladecellekræft i hoved og hals

Kina
Eben Rosenthal
National Cancer Institute (NCI)

Afsluttet

Cetuximab-IRDye 800CW og intraoperativ billeddannelse til at finde kræft i bugspytkirtlen hos patienter, der gennemgår kirurgi

Adenocarcinom i bugspytkirtlen

Forenede Stater
HiberCell, Inc.

Afsluttet

Undersøgelse af Imprime PGG® i kombination med Cetuximab hos forsøgspersoner med tilbagevendende eller progressiv KRAS vildtype kolorektal cancer (PRIMUS)

Kolorektal cancer

Forenede Stater, Puerto Rico, Tyskland, Frankrig
Merck KGaA, Darmstadt, Germany

Afsluttet

Undersøgelse for at evaluere effektiviteten og sikkerheden af FOLFOX-4 Plus Cetuximab versus UFOX Plus Cetuximab. (FUTURE)

Tidligere ubehandlet metastatisk tyktarmskræft

Frankrig, Italien, Polen, Tyskland, Hong Kong, Østrig, Brasilien, Israel, Grækenland, Argentina, Thailand, Belgien, Australien, Mexico
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme LLC

Afsluttet

Biomarkør-rettet behandling ved metastatisk kolorektal cancer

Metastatisk tyktarmskræft

Østrig

S0205 Gemcitabin m/ eller uden Cetuximab som førstelinjebehandling ved lokalt avanceret bugspytkirtelkræft

Et fase III randomiseret åbent studie, der sammenligner Gemcitabine Plus Cetuximab (IMC-C225) versus Gemcitabin som førstelinjebehandling af patienter med avanceret bugspytkirtelkræft

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Kræft i bugspytkirtlen

Kliniske forsøg med cetuximab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer