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Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer

21. februar 2017 opdateret af: Alliance for Clinical Trials in Oncology

Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, 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. Panitumumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor.

PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in treating patients with metastatic pancreatic cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Kræft i bugspytkirtlen

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib hydrochloride results in an improvement in overall survival of patients with previously untreated, metastatic adenocarcinoma of the pancreas.

Secondary

To compare objective response rates, progression-free survival, time to treatment failure, quality of life, and adverse event rates in patients treated with these regimens.
To evaluate the downstream marker, KRAS, in stool specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression (using the first progression tumor measurements as the new baseline reference).
Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and panitumumab every 2 weeks until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression (using the first progression tumor measurements as the new baseline reference).

Stool samples are collected at baseline and analyzed for KRAS mutations via protein analyses.

Quality of life will be assessed at baseline, every 2 courses during treatment, and at the end of treatment.

After the second progression, patients are followed every 3-6 months for 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- Colorado
  - Aurora, Colorado, Forenede Stater, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, Forenede Stater, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, Forenede Stater, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, Forenede Stater, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, Forenede Stater, 80220
    - Rose Medical Center
  - Denver, Colorado, Forenede Stater, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, Forenede Stater, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, Forenede Stater, 80218
    - St. Joseph Hospital
  - Denver, Colorado, Forenede Stater, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, Forenede Stater, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, Forenede Stater, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, Forenede Stater, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, Forenede Stater, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, Forenede Stater, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, Forenede Stater, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, Forenede Stater, 80539
    - McKee Medical Center
  - Thornton, Colorado, Forenede Stater, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, Forenede Stater, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, Forenede Stater, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Florida
  - Jacksonville, Florida, Forenede Stater, 32224
    - Mayo Clinic - Jacksonville
- Hawaii
  - Aiea, Hawaii, Forenede Stater, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Forenede Stater, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, Forenede Stater, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, Forenede Stater, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Wailuku, Hawaii, Forenede Stater, 96793
    - Pacific Cancer Institute - Maui
- Illinois
  - Bloomington, Illinois, Forenede Stater, 61701
    - St. Joseph Medical Center
  - Bloomington%, Illinois, Forenede Stater, 61701
    - Illinois CancerCare - Bloomington
  - Canton, Illinois, Forenede Stater, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, Forenede Stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Memorial Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Illinois CancerCare - Carthage
  - Eureka, Illinois, Forenede Stater, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, Forenede Stater, 62644
    - Mason District Hospital
  - Havana, Illinois, Forenede Stater, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, Forenede Stater, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Macomb, Illinois, Forenede Stater, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, Forenede Stater, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, Forenede Stater, 61265
  - Moline, Illinois, Forenede Stater, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Monmouth, Illinois, Forenede Stater, 61462
    - Illinois CancerCare - Monmouth
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center
  - Normal, Illinois, Forenede Stater, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, Forenede Stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forenede Stater, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Forenede Stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, Forenede Stater, 61603
    - Illinois CancerCare - Pekin
  - 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, PC - Peoria
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Illinois CancerCare - Princeton
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Illinois CancerCare - Spring Valley
- Indiana
  - Beech Grove, Indiana, Forenede Stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, Forenede Stater, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, Forenede Stater, 46514-2098
    - Elkhart Clinic, LLC
  - Kokomo, Indiana, Forenede Stater, 46904
    - Howard Community Hospital
  - La Porte, Indiana, Forenede Stater, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Richmond, Indiana, Forenede Stater, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, Forenede Stater, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, Forenede Stater, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, Forenede Stater, 46617
    - Saint Joseph Regional Medical Center
  - South Bend, Indiana, Forenede Stater, 46617
    - South Bend Clinic
  - South Bend, Indiana, Forenede Stater, 46601
    - Michiana Hematology-Oncology, PC - South Bend
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, Forenede Stater, 52722
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Clive, Iowa, Forenede Stater, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Des Moines, Iowa, Forenede Stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forenede Stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forenede Stater, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, Forenede Stater, 50307
    - Mercy Capitol Hospital
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forenede Stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Forenede Stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forenede Stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, Forenede Stater, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, Forenede Stater, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, Forenede Stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, Forenede Stater, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, Forenede Stater, 67905
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, Forenede Stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forenede Stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forenede Stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forenede Stater, 67401
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, Forenede Stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forenede Stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - 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, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, Forenede Stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Ochsner Health Center - Bluebonnet
  - Covington, Louisiana, Forenede Stater, 70433
    - Ochsner Health Center - Covington
  - New Orleans, Louisiana, Forenede Stater, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, Forenede Stater, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
- Michigan
  - Adrian, Michigan, Forenede Stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, Forenede Stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, Forenede Stater, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, Forenede Stater, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, Forenede Stater, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, Forenede Stater, 49201
    - Foote Memorial Hospital
  - Lambertville, Michigan, Forenede Stater, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Lansing, Michigan, Forenede Stater, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, Forenede Stater, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, Forenede Stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forenede Stater, 48162
    - Mercy Memorial Hospital - Monroe
  - Pontiac, Michigan, Forenede Stater, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, Forenede Stater, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, Forenede Stater, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, Forenede Stater, 49085
    - Lakeside Cancer Specialists, PLLC
  - St. Joseph, Michigan, Forenede Stater, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, Forenede Stater, 48093
    - St. John Macomb Hospital
- Minnesota
  - Alexandria, Minnesota, Forenede Stater, 56308
  - Bemidji, Minnesota, Forenede Stater, 56601
    - MeritCare Bemidji
  - 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
  - Fergus Falls, Minnesota, Forenede Stater, 56537
    - Fergus Falls Medical Group, PA
  - Fridley, Minnesota, Forenede Stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forenede Stater, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, Forenede Stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, Forenede Stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, Forenede Stater, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, Forenede Stater, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - Shakopee, Minnesota, Forenede Stater, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St. Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- 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 Cancer Care Services
  - Billings, Montana, Forenede Stater, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forenede Stater, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Forenede Stater, 59405
  - Great Falls, Montana, Forenede Stater, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, Forenede Stater, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, Forenede Stater, 59501
    - Northern Montana Hospital
  - Helena, Montana, Forenede Stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forenede Stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, Forenede Stater, 59804
    - Guardian Oncology and Center for Wellness
  - 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
  - Lincoln, Nebraska, Forenede Stater, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, Forenede Stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forenede Stater, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, Forenede Stater, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, Forenede Stater, 68131-2197
    - Creighton University Medical Center
- North Carolina
  - Rutherfordton, North Carolina, Forenede Stater, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forenede Stater, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Forenede Stater, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Forenede Stater, 58122
    - MeritCare Broadway
  - Grand Forks, North Dakota, Forenede Stater, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Bowling Green, Ohio, Forenede Stater, 43402
    - Wood County Oncology Center
  - Clyde, Ohio, Forenede Stater, 43410
    - North Coast Cancer Care - Clyde
  - Dayton, Ohio, Forenede Stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forenede Stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forenede Stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forenede Stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forenede Stater, 45420
    - CCOP - Dayton
  - Elyria, Ohio, Forenede Stater, 44035
    - Community Cancer Center
  - Elyria, Ohio, Forenede Stater, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, Forenede Stater, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, Forenede Stater, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, Forenede Stater, 45331
    - Wayne Hospital
  - Kettering, Ohio, Forenede Stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, Forenede Stater, 43537
    - St. Luke's Hospital
  - Maumee, Ohio, Forenede Stater, 43537-1839
    - Northwest Ohio Oncology Center
  - Norwalk, Ohio, Forenede Stater, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, Forenede Stater, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Forenede Stater, 44870
    - North Coast Cancer Care, Incorporated
  - Sylvania, Ohio, Forenede Stater, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, Forenede Stater, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, Forenede Stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forenede Stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forenede Stater, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Forenede Stater, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forenede Stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, Forenede Stater, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, Forenede Stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Forenede Stater, 43567
    - Fulton County Health Center
  - Wilmington, Ohio, Forenede Stater, 45177
    - Clinton Memorial Hospital
  - Xenia, Ohio, Forenede Stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Oregon
  - Milwaukie, Oregon, Forenede Stater, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, Forenede Stater, 97216
    - Adventist Medical Center
  - 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
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Danville, Pennsylvania, Forenede Stater, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, Forenede Stater, 18201
    - Geisinger Hazleton Cancer Center
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Guthrie Cancer Center at Guthrie Clinic Sayre
  - State College, Pennsylvania, Forenede Stater, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - AnMed Cancer Center
  - 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
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, Forenede Stater, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, Forenede Stater, 22401
    - Fredericksburg Oncology, Incorporated
- Washington
  - Vancouver, Washington, Forenede Stater, 98668
    - Southwest Washington Medical Center Cancer Center
- Wisconsin
  - Chippewa Falls, Wisconsin, Forenede Stater, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, Forenede Stater, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Eau Claire, Wisconsin, Forenede Stater, 54703-1510
    - Midelfort Clinic - Luther
  - Eau Claire, Wisconsin, Forenede Stater, 54702
    - Luther Midlelfort Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Manitowoc, Wisconsin, Forenede Stater, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, Forenede Stater, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, Forenede Stater, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, Forenede Stater, 54548
    - Marshfield Clinic - Lakeland Center
  - Oconto Falls, Wisconsin, Forenede Stater, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Rhinelander, Wisconsin, Forenede Stater, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, Forenede Stater, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, Forenede Stater, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, Forenede Stater, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Wausau, Wisconsin, Forenede Stater, 54401
    - Marshfield Clinic - Wausau Center
  - Weston, Wisconsin, Forenede Stater, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, Forenede Stater, 82609
    - Rocky Mountain Oncology
  - 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

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or undifferentiated)
- Metastatic disease
No islet cell, acinar cell, or cystadenocarcinomas
No locally advanced disease
No history or known presence of CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy ≥ 3 months
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)
AST ≤ 2.5 times ULN
Creatinine ≤ 2.0 times ULN
Magnesium ≥ lower limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Willing to provide a stool specimen
No malignancy diagnosed within the past 3 years except basal cell or squamous cell skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix
No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
No clinically significant cardiovascular disease (i.e., myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) within the past year
No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic active hepatitis B infection
No liver dysfunction from cirrhosis or viral hepatitis
No enteral hyperalimentation
No grapefruit or grapefruit juice during the study

PRIOR CONCURRENT THERAPY:

Recovered from prior therapy
More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy
More than 4 weeks since prior and no elective or planned major surgery
More than 2 weeks since prior minor and no elective or planned surgery
No prior cytotoxic chemotherapy for metastatic disease
- Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed, provided it was administered > 6 months prior to study entry
  - Adjuvant chemotherapy must not have contained an EGFR inhibitor
- Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance therapy is allowed, provided more than 6 months have elapsed since the last day of treatment
No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)
No concurrent immunotherapy or radiotherapy
No other concurrent chemotherapy
No concurrent colony-stimulating factors during the first course of study therapy

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
Aktiv komparator: Arm A: GE Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.	Medicin: gemcitabin hydrochlorid Givet IV Medicin: erlotinib hydrochlorid Gives oralt
Eksperimentel: Arm B: PGE Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.	Medicin: gemcitabin hydrochlorid Givet IV Medicin: erlotinib hydrochlorid Gives oralt Biologisk: panitumumab Givet IV

Deltagergruppe / Arm

Intervention / Behandling

Aktiv komparator: Arm A: GE

Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.

Medicin: gemcitabin hydrochlorid

Givet IV

Medicin: erlotinib hydrochlorid

Gives oralt

Eksperimentel: Arm B: PGE

Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.

Medicin: gemcitabin hydrochlorid

Givet IV

Medicin: erlotinib hydrochlorid

Gives oralt

Biologisk: panitumumab

Givet IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Survival Tidsramme: Up to 2 years	Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.	Up to 2 years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Confirmed Response Rate Tidsramme: Up to 2 years	Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.	Up to 2 years
Progression-free Survival Tidsramme: Up to 2 years	Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test.	Up to 2 years
Time to Treatment Failure Tidsramme: Up to 2 years	Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier.	Up to 2 years
Frequency and Severity of Observed Adverse Effects Tidsramme: Up to 2 years	Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported. A complete listing of all adverse events is reported in the Adverse Events section.	Up to 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: George P. Kim, MD, Mayo Clinic

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

Halfdanarson TR, Foster NR, Kim GP, Meyers JP, Smyrk TC, McCullough AE, Ames MM, Jaffe JP, Alberts SR. A Phase II Randomized Trial of Panitumumab, Erlotinib, and Gemcitabine Versus Erlotinib and Gemcitabine in Patients with Untreated, Metastatic Pancreatic Adenocarcinoma: North Central Cancer Treatment Group Trial N064B (Alliance). Oncologist. 2019 May;24(5):589-e160. doi: 10.1634/theoncologist.2018-0878. Epub 2019 Jan 24.

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. marts 2009

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

26. oktober 2007

Først indsendt, der opfyldte QC-kriterier

26. oktober 2007

Først opslået (Skøn)

30. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCCTG-N064B
NCI-2009-01089 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000571863 (Registry Identifier: PDQ (Physician Data Query))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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

Ikke rekrutterer endnu

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 gemcitabin hydrochlorid

Beth Christian

Afsluttet

Gemcitabin og Bendamustine hos patienter med recidiverende eller refraktær Hodgkins lymfom

Tilbagevendende voksen Hodgkin-lymfom | Voksen lymfocytdepletion Hodgkin lymfom | Voksen lymfocytdominerende Hodgkin-lymfom | Hodgkin-lymfom med blandet cellularitet hos voksne | Nodulær sklerose hos voksne Hodgkin-lymfom | Voksen nodulær lymfocytdominerende Hodgkin-lymfom

Forenede Stater
OSI Pharmaceuticals
National Cancer Institute (NCI)

Afsluttet

Erlotinib kombineret med gemcitabin til behandling af patienter med nyligt diagnosticeret lokalt avanceret eller metastatisk bugspytkirtelkræft eller andre solide tumorer

Kræft i bugspytkirtlen | Uspecificeret fast tumor hos voksne, protokolspecifik

Forenede Stater
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Afsluttet

Erlotinib og Gemcitabin til behandling af patienter med metastatisk brystkræft, der tidligere er behandlet med en antracyklin og/eller en taxan

Brystkræft

Forenede Stater
NCIC Clinical Trials Group

Afsluttet

Gemcitabin med/uden erlotinib i uoperabel lokalt avanceret/metastatisk bugspytkirtelkræft

Kræft i bugspytkirtlen

Forenede Stater, Canada, Australien, Singapore, Belgien, Det Forenede Kongerige, Israel, New Zealand, Kina, Tyskland, Brasilien, Polen, Italien, Argentina, Rumænien, Grækenland, Chile, Hong Kong, Mexico
NCIC Clinical Trials Group

Afsluttet

Bortezomib og Gemcitabin til behandling af patienter med recidiverende mantelcellelymfom

Lymfom

Canada
National Cancer Institute (NCI)

Afsluttet

Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

Adenocarcinom i bugspytkirtlen | Tilbagevendende kræft i bugspytkirtlen | Stadie III Bugspytkirtelkræft | Fase II Kræft i bugspytkirtlen

Forenede Stater
Institut du Cancer de Montpellier - Val d'Aurelle

Afsluttet

Gemcitabin med eller uden oxaliplatin til behandling af patienter med lokalt avanceret eller metastatisk blærekræft

Blærekræft

Frankrig
Institute of Liver and Biliary Sciences, India

Rekruttering

Rotationstromboelastometri versus konventionelle hæmostatiske test hos børn med dekompenseret skrumpelever, der gennemgår invasive procedurer.

Dekompenseret skrumpelever

Indien
Tripler Army Medical Center

Trukket tilbage

Glyburid sammenlignet med insulin i behandlingen af hvids klassifikation A2 svangerskabsdiabetes

Svangerskabsdiabetes

Forenede Stater
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)

Afsluttet

Ph II Gemcitabin, Erlotinib og Gemcitabin med Erlotinib/ældre patienter W/IIIB/IV NSCLC

Lungekræft

Forenede Stater

Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer

Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma

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

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

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 (Faktiske)

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 gemcitabin hydrochlorid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer