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

2017년 2월 21일 업데이트: 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.

연구 개요

상태

완전한

정황

췌장암

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

104

단계

2 단계

연락처 및 위치

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연구 장소

미국
- Colorado
  - Aurora, Colorado, 미국, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, 미국, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, 미국, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, 미국, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, 미국, 80220
    - Rose Medical Center
  - Denver, Colorado, 미국, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, 미국, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, 미국, 80218
    - St. Joseph Hospital
  - Denver, Colorado, 미국, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, 미국, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, 미국, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, 미국, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, 미국, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, 미국, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, 미국, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, 미국, 80539
    - McKee Medical Center
  - Thornton, Colorado, 미국, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, 미국, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, 미국, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Florida
  - Jacksonville, Florida, 미국, 32224
    - Mayo Clinic - Jacksonville
- Hawaii
  - Aiea, Hawaii, 미국, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, 미국, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, 미국, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, 미국, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, 미국, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, 미국, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, 미국, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, 미국, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Wailuku, Hawaii, 미국, 96793
    - Pacific Cancer Institute - Maui
- Illinois
  - Bloomington, Illinois, 미국, 61701
    - St. Joseph Medical Center
  - Bloomington%, Illinois, 미국, 61701
    - Illinois CancerCare - Bloomington
  - Canton, Illinois, 미국, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, 미국, 61520
    - Graham Hospital
  - Carthage, Illinois, 미국, 62321
    - Memorial Hospital
  - Carthage, Illinois, 미국, 62321
    - Illinois CancerCare - Carthage
  - Eureka, Illinois, 미국, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, 미국, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, 미국, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, 미국, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, 미국, 62644
    - Mason District Hospital
  - Havana, Illinois, 미국, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, 미국, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Macomb, Illinois, 미국, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, 미국, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, 미국, 61265
  - Moline, Illinois, 미국, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Monmouth, Illinois, 미국, 61462
    - Illinois CancerCare - Monmouth
  - Normal, Illinois, 미국, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, 미국, 61761
    - Community Cancer Center
  - Normal, Illinois, 미국, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, 미국, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, 미국, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, 미국, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, 미국, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, 미국, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, 미국, 61614
    - Proctor Hospital
  - Peoria, Illinois, 미국, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, 미국, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, 미국, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, 미국, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, 미국, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, 미국, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, 미국, 61356
    - Illinois CancerCare - Princeton
  - Spring Valley, Illinois, 미국, 61362
    - Illinois CancerCare - Spring Valley
- Indiana
  - Beech Grove, Indiana, 미국, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, 미국, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, 미국, 46514-2098
    - Elkhart Clinic, LLC
  - Kokomo, Indiana, 미국, 46904
    - Howard Community Hospital
  - La Porte, Indiana, 미국, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Richmond, Indiana, 미국, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, 미국, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, 미국, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, 미국, 46617
    - Saint Joseph Regional Medical Center
  - South Bend, Indiana, 미국, 46617
    - South Bend Clinic
  - South Bend, Indiana, 미국, 46601
    - Michiana Hematology-Oncology, PC - South Bend
- Iowa
  - Ames, Iowa, 미국, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, 미국, 52722
  - Cedar Rapids, Iowa, 미국, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, 미국, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Clive, Iowa, 미국, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Des Moines, Iowa, 미국, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, 미국, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, 미국, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, 미국, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, 미국, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, 미국, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, 미국, 50307
    - Mercy Capitol Hospital
  - Sioux City, Iowa, 미국, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, 미국, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, 미국, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, 미국, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, 미국, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, 미국, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, 미국, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, 미국, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, 미국, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, 미국, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, 미국, 67905
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, 미국, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, 미국, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, 미국, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, 미국, 67401
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, 미국, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, 미국, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, 미국, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, 미국, 67214
    - CCOP - Wichita
  - Wichita, Kansas, 미국, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, 미국, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, 미국, 67156
    - Cancer Center of Kansas, PA - Winfield
- Louisiana
  - Baton Rouge, Louisiana, 미국, 70809
    - Ochsner Health Center - Bluebonnet
  - Covington, Louisiana, 미국, 70433
    - Ochsner Health Center - Covington
  - New Orleans, Louisiana, 미국, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, 미국, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
- Michigan
  - Adrian, Michigan, 미국, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, 미국, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, 미국, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, 미국, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, 미국, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, 미국, 48503
    - Hurley Medical Center
  - Flint, Michigan, 미국, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, 미국, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, 미국, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, 미국, 49201
    - Foote Memorial Hospital
  - Lambertville, Michigan, 미국, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Lansing, Michigan, 미국, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, 미국, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, 미국, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, 미국, 48162
    - Mercy Memorial Hospital - Monroe
  - Pontiac, Michigan, 미국, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, 미국, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, 미국, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, 미국, 49085
    - Lakeside Cancer Specialists, PLLC
  - St. Joseph, Michigan, 미국, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, 미국, 48093
    - St. John Macomb Hospital
- Minnesota
  - Alexandria, Minnesota, 미국, 56308
  - Bemidji, Minnesota, 미국, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, 미국, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, 미국, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Edina, Minnesota, 미국, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, 미국, 56537
    - Fergus Falls Medical Group, PA
  - Fridley, Minnesota, 미국, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, 미국, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, 미국, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, 미국, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, 미국, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, 미국, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, 미국, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, 미국, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, 미국, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, 미국, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, 미국, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, 미국, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, 미국, 55102
    - United Hospital
  - Shakopee, Minnesota, 미국, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St. Paul, Minnesota, 미국, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, 미국, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, 미국, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Montana
  - Billings, Montana, 미국, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, 미국, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, 미국, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, 미국, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, 미국, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, 미국, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, 미국, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, 미국, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, 미국, 59405
  - Great Falls, Montana, 미국, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, 미국, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, 미국, 59501
    - Northern Montana Hospital
  - Helena, Montana, 미국, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, 미국, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, 미국, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, 미국, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, 미국, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, 미국, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Lincoln, Nebraska, 미국, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, 미국, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, 미국, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, 미국, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, 미국, 68131-2197
    - Creighton University Medical Center
- North Carolina
  - Rutherfordton, North Carolina, 미국, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, 미국, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, 미국, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, 미국, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, 미국, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, 미국, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, 미국, 58122
    - MeritCare Broadway
  - Grand Forks, North Dakota, 미국, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Bowling Green, Ohio, 미국, 43402
    - Wood County Oncology Center
  - Clyde, Ohio, 미국, 43410
    - North Coast Cancer Care - Clyde
  - Dayton, Ohio, 미국, 45405
    - Grandview Hospital
  - Dayton, Ohio, 미국, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, 미국, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, 미국, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, 미국, 45420
    - CCOP - Dayton
  - Elyria, Ohio, 미국, 44035
    - Community Cancer Center
  - Elyria, Ohio, 미국, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, 미국, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, 미국, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, 미국, 45331
    - Wayne Hospital
  - Kettering, Ohio, 미국, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, 미국, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, 미국, 43537
    - St. Luke's Hospital
  - Maumee, Ohio, 미국, 43537-1839
    - Northwest Ohio Oncology Center
  - Norwalk, Ohio, 미국, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, 미국, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, 미국, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, 미국, 44870
    - North Coast Cancer Care, Incorporated
  - Sylvania, Ohio, 미국, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, 미국, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, 미국, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, 미국, 43606
    - Toledo Hospital
  - Toledo, Ohio, 미국, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, 미국, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, 미국, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, 미국, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, 미국, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, 미국, 43567
    - Fulton County Health Center
  - Wilmington, Ohio, 미국, 45177
    - Clinton Memorial Hospital
  - Xenia, Ohio, 미국, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma
  - Tulsa, Oklahoma, 미국, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Oregon
  - Milwaukie, Oregon, 미국, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, 미국, 97216
    - Adventist Medical Center
  - Portland, Oregon, 미국, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, 미국, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, 미국, 97225
    - Providence St. Vincent Medical Center
- Pennsylvania
  - Allentown, Pennsylvania, 미국, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Danville, Pennsylvania, 미국, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, 미국, 18201
    - Geisinger Hazleton Cancer Center
  - Sayre, Pennsylvania, 미국, 18840
    - Guthrie Cancer Center at Guthrie Clinic Sayre
  - State College, Pennsylvania, 미국, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, 미국, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Carolina
  - Anderson, South Carolina, 미국, 29621
    - AnMed Cancer Center
  - Spartanburg, South Carolina, 미국, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, 미국, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, 미국, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, 미국, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, 미국, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, 미국, 22401
    - Fredericksburg Oncology, Incorporated
- Washington
  - Vancouver, Washington, 미국, 98668
    - Southwest Washington Medical Center Cancer Center
- Wisconsin
  - Chippewa Falls, Wisconsin, 미국, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, 미국, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Eau Claire, Wisconsin, 미국, 54703-1510
    - Midelfort Clinic - Luther
  - Eau Claire, Wisconsin, 미국, 54702
    - Luther Midlelfort Hospital
  - Green Bay, Wisconsin, 미국, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, 미국, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, 미국, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, 미국, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Manitowoc, Wisconsin, 미국, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, 미국, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, 미국, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, 미국, 54548
    - Marshfield Clinic - Lakeland Center
  - Oconto Falls, Wisconsin, 미국, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Rhinelander, Wisconsin, 미국, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, 미국, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, 미국, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, 미국, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Wausau, Wisconsin, 미국, 54401
    - Marshfield Clinic - Wausau Center
  - Weston, Wisconsin, 미국, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, 미국, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, 미국, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, 미국, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
활성 비교기: 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.	의약품: 젬시타빈염산염 주어진 IV 의약품: 에를로티닙 염산염 구두로 주어진
실험적: 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.	의약품: 젬시타빈염산염 주어진 IV 의약품: 에를로티닙 염산염 구두로 주어진 생물학적: 파니투무맙 주어진 IV

참가자 그룹 / 팔

개입 / 치료

활성 비교기: 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.

의약품: 젬시타빈염산염

주어진 IV

의약품: 에를로티닙 염산염

구두로 주어진

실험적: 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.

의약품: 젬시타빈염산염

주어진 IV

의약품: 에를로티닙 염산염

구두로 주어진

생물학적: 파니투무맙

주어진 IV

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Overall Survival 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Confirmed Response Rate 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

수사관

연구 의자: George P. Kim, MD, Mayo Clinic

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 3월 1일

기본 완료 (실제)

2010년 11월 1일

연구 완료 (실제)

2013년 5월 1일

연구 등록 날짜

최초 제출

2007년 10월 26일

QC 기준을 충족하는 최초 제출

2007년 10월 26일

처음 게시됨 (추정)

2007년 10월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 21일

마지막으로 확인됨

2017년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

췌장암에 대한 임상 시험

Georgetown University
National Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...

완전한

중국 여성 및 유방조영술 검진

American Cancer Society 유방조영술 검진 지침을 준수하지 않은 중국 여성 연구

미국
University of Utah
National Cancer Institute (NCI)

완전한

전이성 전립선암 환자를 위한 저항 운동 +/- 크레아틴

피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8

미국
SB Istanbul Education and Research Hospital

아직 모집하지 않음

새로운 수술 중 신경 모니터링 장치 (IONM)

Thryoid cancer | parathyrıoid 선종
Jonsson Comprehensive Cancer Center
Novartis Pharmaceuticals

모병

전이성 거세 저항성 전립선암 치료를 위한 177Lu-PSMA-617의 유연한 투여 일정 평가

전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8

미국
Jonsson Comprehensive Cancer Center

모병

전립선암 치료를 위한 국소 방사선 치료 (고선량률 근접 방사선 치료)

전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8

미국
Jonsson Comprehensive Cancer Center

빼는

저위험 또는 중간 위험 전립선암 치료를 위한 국소 방사선 요법

전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8

미국
Jonsson Comprehensive Cancer Center
MiraDX

모집하지 않고 적극적으로

생식계열 DNA 기반 방사선감수성 바이오마커가 전립선 방사선 치료 후 독성에 미치는 영향, GARUDA 시험 (GARUDA)

전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8

미국
Society for Endocrinology

초대로 등록

부신 종양에 대한 국가 연구 (NSAT)

부신 종양 | 페로 크로 모세포종 및 paraganglioma (PPGL) | Adrenocorticol Cancer (ACC)

영국
Jonsson Comprehensive Cancer Center

모병

177Lu-PSMA 방사성리간드 요법으로 치료한 전이성 거세 저항성 전립선암 환자의 저항 메커니즘을 식별하기 위한 이미지 유도 생검

거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8

미국
Jonsson Comprehensive Cancer Center

종료됨

거세 저항성 전립선암 환자의 68Ga-PSMA-11 PET/CT 영상에 대한 안드로겐 수용체 신호 억제제의 효과

거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8

미국

젬시타빈염산염에 대한 임상 시험

Haihe Biopharma Co., Ltd.
Shanghai Institute of Materia Medica, Chinese Academy of Sciences

완전한

진행성 고형 종양 치료에서 Simmitecan Hydrochloride의 연구

고급 고형 종양

중국
Boehringer Ingelheim

완전한

건강한 남녀 지원자에서 암브록솔 염산염 시럽과 비교한 연질 알약의 암브록솔 염산염의 상대적 생체이용률

건강한
Torrent Pharmaceuticals Limited

완전한

급식 조건에서 Torrent Pharmaceuticals Ltd의 Pioglitazone Hydrochloride 및 Metformin Hydrochloride 정제의 생물학적 동등성 연구

건강한

인도
Bing He

모집하지 않고 적극적으로

중국의 비만이 아닌 PCOS 환자에서 Metformin과 Pioglitazone 병용이 생식선 및 대사 프로필에 미치는 영향.

다낭성 난소 증후군

중국
Shanghai University of Traditional Chinese Medicine

아직 모집하지 않음

중간 및 고위험 비 근육-비 침습적 방광암에서 재발을 예방하기위한 젬시 타빈 하위 점막 주사의 효능 : 무작위 시험 (GEM-IR-NMIBC)

비근육침습성 방광암
University Hospital Southampton NHS Foundation...
University of Southampton

빼는

변실금에 대한 이모듐 시럽 대 이모듐 정제

변실금

영국
Torrent Pharmaceuticals Limited

완전한

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions

건강한

인도
Duan Minghui

아직 모집하지 않음

PV 환자를 대상으로 한 Gecacitinib과 Pegylated Interferon 병용 임상 연구

진성적혈구증가증(PV)
Yujun DONG

모병

CGVHD에 대한 Gecacitinib : 이전 치료의 ≥2 라인 후 환자의 안전성 및 효능

만성 이식편 대 숙주병

중국
Aziende Chimiche Riunite Angelini Francesco S.p.A
Zak-Pharma Dienstleistung Ges.m.b.H.

완전한

인후염 통증 완화의 벤지다민(BePaiR 연구) (BePaiR)

급성 인후염

헝가리, 폴란드, 러시아 연방

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

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (실제)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

협력자

수사관

간행물 및 유용한 링크

일반 간행물

연구 기록 날짜

연구 주요 날짜

연구 시작

기본 완료 (실제)

연구 완료 (실제)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (추정)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

췌장암에 대한 임상 시험

젬시타빈염산염에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Sri Lanka

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치