- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00550836
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
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, Stati Uniti, 80301-9019
- Boulder Community Hospital
-
Colorado Springs, Colorado, Stati Uniti, 80933
- Penrose Cancer Center at Penrose Hospital
-
Denver, Colorado, Stati Uniti, 80210
- Porter Adventist Hospital
-
Denver, Colorado, Stati Uniti, 80220
- Rose Medical Center
-
Denver, Colorado, Stati Uniti, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Stati Uniti, 80204
- St. Anthony Central Hospital
-
Denver, Colorado, Stati Uniti, 80218
- St. Joseph Hospital
-
Denver, Colorado, Stati Uniti, 80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood, Colorado, Stati Uniti, 80110
- Swedish Medical Center
-
Fort Collins, Colorado, Stati Uniti, 80528
- Front Range Cancer Specialists
-
Grand Junction, Colorado, Stati Uniti, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Greeley, Colorado, Stati Uniti, 80631
- North Colorado Medical Center
-
Lone Tree, Colorado, Stati Uniti, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, Stati Uniti, 80501
- Hope Cancer Care Center at Longmont United Hospital
-
Loveland, Colorado, Stati Uniti, 80539
- McKee Medical Center
-
Thornton, Colorado, Stati Uniti, 80229
- North Suburban Medical Center
-
Wheat Ridge, Colorado, Stati Uniti, 80033
- Exempla Lutheran Medical Center
-
-
Connecticut
-
Hartford, Connecticut, Stati Uniti, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
-
-
Florida
-
Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic - Jacksonville
-
-
Hawaii
-
Aiea, Hawaii, Stati Uniti, 96701
- Kapiolani Medical Center at Pali Momi
-
Honolulu, Hawaii, Stati Uniti, 96813
- Cancer Research Center of Hawaii
-
Honolulu, Hawaii, Stati Uniti, 96826
- Kapiolani Medical Center for Women and Children
-
Honolulu, Hawaii, Stati Uniti, 96813
- OnCare Hawaii, Incorporated - Lusitana
-
Honolulu, Hawaii, Stati Uniti, 96813
- Queen's Cancer Institute at Queen's Medical Center
-
Honolulu, Hawaii, Stati Uniti, 96813
- Straub Clinic and Hospital, Incorporated
-
Honolulu, Hawaii, Stati Uniti, 96817
- Hawaii Medical Center - East
-
Honolulu, Hawaii, Stati Uniti, 96817
- OnCare Hawaii, Incorporated - Kuakini
-
Wailuku, Hawaii, Stati Uniti, 96793
- Pacific Cancer Institute - Maui
-
-
Illinois
-
Bloomington, Illinois, Stati Uniti, 61701
- St. Joseph Medical Center
-
Bloomington%, Illinois, Stati Uniti, 61701
- Illinois CancerCare - Bloomington
-
Canton, Illinois, Stati Uniti, 61520
- Illinois CancerCare - Canton
-
Canton, Illinois, Stati Uniti, 61520
- Graham Hospital
-
Carthage, Illinois, Stati Uniti, 62321
- Memorial Hospital
-
Carthage, Illinois, Stati Uniti, 62321
- Illinois CancerCare - Carthage
-
Eureka, Illinois, Stati Uniti, 61530
- Illinois CancerCare - Eureka
-
Eureka, Illinois, Stati Uniti, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Stati Uniti, 61401
- Illinois CancerCare - Galesburg
-
Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, Stati Uniti, 62644
- Mason District Hospital
-
Havana, Illinois, Stati Uniti, 62644
- Illinois CancerCare - Havana
-
Kewanee, Illinois, Stati Uniti, 61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb, Illinois, Stati Uniti, 61455
- Illinois CancerCare - Macomb
-
Macomb, Illinois, Stati Uniti, 61455
- Mcdonough District Hospital
-
Moline, Illinois, Stati Uniti, 61265
-
Moline, Illinois, Stati Uniti, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth, Illinois, Stati Uniti, 61462
- Illinois CancerCare - Monmouth
-
Normal, Illinois, Stati Uniti, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Stati Uniti, 61761
- Community Cancer Center
-
Normal, Illinois, Stati Uniti, 61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa, Illinois, Stati Uniti, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Stati Uniti, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, Stati Uniti, 61554
- Cancer Treatment Center at Pekin Hospital
-
Pekin, Illinois, Stati Uniti, 61603
- Illinois CancerCare - Pekin
-
Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Stati Uniti, 61614
- Proctor Hospital
-
Peoria, Illinois, Stati Uniti, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Stati Uniti, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Stati Uniti, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, Stati Uniti, 61354
- Illinois CancerCare - Peru
-
Peru, Illinois, Stati Uniti, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Stati Uniti, 61356
- Perry Memorial Hospital
-
Princeton, Illinois, Stati Uniti, 61356
- Illinois CancerCare - Princeton
-
Spring Valley, Illinois, Stati Uniti, 61362
- Illinois CancerCare - Spring Valley
-
-
Indiana
-
Beech Grove, Indiana, Stati Uniti, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Elkhart, Indiana, Stati Uniti, 46515
- Elkhart General Hospital
-
Elkhart, Indiana, Stati Uniti, 46514-2098
- Elkhart Clinic, LLC
-
Kokomo, Indiana, Stati Uniti, 46904
- Howard Community Hospital
-
La Porte, Indiana, Stati Uniti, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
-
Richmond, Indiana, Stati Uniti, 47374
- Reid Hospital & Health Care Services
-
South Bend, Indiana, Stati Uniti, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Stati Uniti, 46601
- CCOP - Northern Indiana CR Consortium
-
South Bend, Indiana, Stati Uniti, 46617
- Saint Joseph Regional Medical Center
-
South Bend, Indiana, Stati Uniti, 46617
- South Bend Clinic
-
South Bend, Indiana, Stati Uniti, 46601
- Michiana Hematology-Oncology, PC - South Bend
-
-
Iowa
-
Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic, PC
-
Bettendorf, Iowa, Stati Uniti, 52722
-
Cedar Rapids, Iowa, Stati Uniti, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
-
Clive, Iowa, Stati Uniti, 50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Des Moines, Iowa, Stati Uniti, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Stati Uniti, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Stati Uniti, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Stati Uniti, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Stati Uniti, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Stati Uniti, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, Stati Uniti, 50307
- Mercy Capitol Hospital
-
Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Stati Uniti, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Stati Uniti, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute, Kansas, Stati Uniti, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, Stati Uniti, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, Stati Uniti, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Fort Scott, Kansas, Stati Uniti, 66701
- Cancer Center of Kansas - Fort Scott
-
Independence, Kansas, Stati Uniti, 67301
- Cancer Center of Kansas-Independence
-
Kingman, Kansas, Stati Uniti, 67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence, Kansas, Stati Uniti, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, Stati Uniti, 67905
- Cancer Center of Kansas, PA - Liberal
-
Newton, Kansas, Stati Uniti, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Stati Uniti, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Stati Uniti, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Stati Uniti, 67401
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, Stati Uniti, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, Stati Uniti, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Stati Uniti, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, Stati Uniti, 67214
- CCOP - Wichita
-
Wichita, Kansas, Stati Uniti, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, Stati Uniti, 67208
- Associates in Womens Health, PA - North Review
-
Winfield, Kansas, Stati Uniti, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Louisiana
-
Baton Rouge, Louisiana, Stati Uniti, 70809
- Ochsner Health Center - Bluebonnet
-
Covington, Louisiana, Stati Uniti, 70433
- Ochsner Health Center - Covington
-
New Orleans, Louisiana, Stati Uniti, 70121
- CCOP - Ochsner
-
New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
-
-
Michigan
-
Adrian, Michigan, Stati Uniti, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Ann Arbor, Michigan, Stati Uniti, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Michigan Cancer Research Consortium
-
Dearborn, Michigan, Stati Uniti, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Escanaba, Michigan, Stati Uniti, 49431
- Green Bay Oncology, Limited - Escanaba
-
Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
-
Flint, Michigan, Stati Uniti, 48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain, Michigan, Stati Uniti, 49801
- Dickinson County Healthcare System
-
Jackson, Michigan, Stati Uniti, 49201
- Foote Memorial Hospital
-
Lambertville, Michigan, Stati Uniti, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Lansing, Michigan, Stati Uniti, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, Stati Uniti, 48154
- St. Mary Mercy Hospital
-
Monroe, Michigan, Stati Uniti, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, Stati Uniti, 48162
- Mercy Memorial Hospital - Monroe
-
Pontiac, Michigan, Stati Uniti, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, Stati Uniti, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, Stati Uniti, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Saint Joseph, Michigan, Stati Uniti, 49085
- Lakeside Cancer Specialists, PLLC
-
St. Joseph, Michigan, Stati Uniti, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
-
Warren, Michigan, Stati Uniti, 48093
- St. John Macomb Hospital
-
-
Minnesota
-
Alexandria, Minnesota, Stati Uniti, 56308
-
Bemidji, Minnesota, Stati Uniti, 56601
- MeritCare Bemidji
-
Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Edina, Minnesota, Stati Uniti, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Stati Uniti, 56537
- Fergus Falls Medical Group, PA
-
Fridley, Minnesota, Stati Uniti, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, Stati Uniti, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, Stati Uniti, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, Stati Uniti, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale, Minnesota, Stati Uniti, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Stati Uniti, 56303
- CentraCare Clinic - River Campus
-
Saint Cloud, Minnesota, Stati Uniti, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, Stati Uniti, 55416
- CCOP - Metro-Minnesota
-
Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Cancer Center
-
Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
-
Shakopee, Minnesota, Stati Uniti, 55379
- St. Francis Cancer Center at St. Francis Medical Center
-
St. Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Montana
-
Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Stati Uniti, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, Stati Uniti, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Stati Uniti, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, Stati Uniti, 59107-7000
- Billings Clinic - Downtown
-
Bozeman, Montana, Stati Uniti, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Stati Uniti, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Stati Uniti, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, Stati Uniti, 59405
-
Great Falls, Montana, Stati Uniti, 59405-5309
- Big Sky Oncology
-
Great Falls, Montana, Stati Uniti, 59405
- Sletten Cancer Institute at Benefis Healthcare
-
Havre, Montana, Stati Uniti, 59501
- Northern Montana Hospital
-
Helena, Montana, Stati Uniti, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Stati Uniti, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Stati Uniti, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, Stati Uniti, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Stati Uniti, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Stati Uniti, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
-
Lincoln, Nebraska, Stati Uniti, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, Stati Uniti, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Stati Uniti, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Stati Uniti, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Stati Uniti, 68131-2197
- Creighton University Medical Center
-
-
North Carolina
-
Rutherfordton, North Carolina, Stati Uniti, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Stati Uniti, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Stati Uniti, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Stati Uniti, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Stati Uniti, 58122
- MeritCare Broadway
-
Grand Forks, North Dakota, Stati Uniti, 58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Bowling Green, Ohio, Stati Uniti, 43402
- Wood County Oncology Center
-
Clyde, Ohio, Stati Uniti, 43410
- North Coast Cancer Care - Clyde
-
Dayton, Ohio, Stati Uniti, 45405
- Grandview Hospital
-
Dayton, Ohio, Stati Uniti, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Stati Uniti, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Stati Uniti, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Stati Uniti, 45420
- CCOP - Dayton
-
Elyria, Ohio, Stati Uniti, 44035
- Community Cancer Center
-
Elyria, Ohio, Stati Uniti, 44035
- Hematology Oncology Center
-
Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, Stati Uniti, 45005-1066
- Middletown Regional Hospital
-
Greenville, Ohio, Stati Uniti, 45331
- Wayne Hospital
-
Kettering, Ohio, Stati Uniti, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, Stati Uniti, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Stati Uniti, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Stati Uniti, 43537-1839
- Northwest Ohio Oncology Center
-
Norwalk, Ohio, Stati Uniti, 44857
- Fisher-Titus Medical Center
-
Oregon, Ohio, Stati Uniti, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Stati Uniti, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Stati Uniti, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Stati Uniti, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Stati Uniti, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Stati Uniti, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Stati Uniti, 43606
- Toledo Hospital
-
Toledo, Ohio, Stati Uniti, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Stati Uniti, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Stati Uniti, 43623
- St. Anne Mercy Hospital
-
Troy, Ohio, Stati Uniti, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Stati Uniti, 43567
- Fulton County Health Center
-
Wilmington, Ohio, Stati Uniti, 45177
- Clinton Memorial Hospital
-
Xenia, Ohio, Stati Uniti, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, Stati Uniti, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Milwaukie, Oregon, Stati Uniti, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Stati Uniti, 97216
- Adventist Medical Center
-
Portland, Oregon, Stati Uniti, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Stati Uniti, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Stati Uniti, 97225
- Providence St. Vincent Medical Center
-
-
Pennsylvania
-
Allentown, Pennsylvania, Stati Uniti, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Stati Uniti, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Stati Uniti, 18201
- Geisinger Hazleton Cancer Center
-
Sayre, Pennsylvania, Stati Uniti, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
-
State College, Pennsylvania, Stati Uniti, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Stati Uniti, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Stati Uniti, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Stati Uniti, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Stati Uniti, 22401
- Fredericksburg Oncology, Incorporated
-
-
Washington
-
Vancouver, Washington, Stati Uniti, 98668
- Southwest Washington Medical Center Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Stati Uniti, 54729
- Marshfield Clinic - Chippewa Center
-
Eau Claire, Wisconsin, Stati Uniti, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
-
Eau Claire, Wisconsin, Stati Uniti, 54703-1510
- Midelfort Clinic - Luther
-
Eau Claire, Wisconsin, Stati Uniti, 54702
- Luther Midlelfort Hospital
-
Green Bay, Wisconsin, Stati Uniti, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stati Uniti, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stati Uniti, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Stati Uniti, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc, Wisconsin, Stati Uniti, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Stati Uniti, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Clinic - Marshfield Center
-
Minocqua, Wisconsin, Stati Uniti, 54548
- Marshfield Clinic - Lakeland Center
-
Oconto Falls, Wisconsin, Stati Uniti, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Rhinelander, Wisconsin, Stati Uniti, 54501
- Ministry Medical Group at Saint Mary's Hospital
-
Rice Lake, Wisconsin, Stati Uniti, 54868
- Marshfield Clinic - Indianhead Center
-
Stevens Point, Wisconsin, Stati Uniti, 54481
- Marshfield Clinic at Saint Michael's Hospital
-
Sturgeon Bay, Wisconsin, Stati Uniti, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Wausau, Wisconsin, Stati Uniti, 54401
- Marshfield Clinic - Wausau Center
-
Weston, Wisconsin, Stati Uniti, 54476
- Marshfield Clinic - Weston Center
-
Wisconsin Rapids, Wisconsin, Stati Uniti, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Casper, Wyoming, Stati Uniti, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, Stati Uniti, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
Dato IV
Dato oralmente
|
|
Sperimentale: 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.
|
Dato IV
Dato oralmente
Dato IV
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Confirmed Response Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: George P. Kim, MD, Mayo Clinic
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Malattie del sistema endocrino
- Neoplasie dell'apparato digerente
- Neoplasie delle ghiandole endocrine
- Malattie pancreatiche
- Neoplasie pancreatiche
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Inibitori della chinasi proteica
- Gemcitabina
- Erlotinib cloridrato
- Panitumumab
Altri numeri di identificazione dello studio
- NCCTG-N064B
- NCI-2009-01089 (Identificatore di registro: CTRP (Clinical Trials Reporting System))
- CDR0000571863 (Identificatore di registro: PDQ (Physician Data Query))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Tumore del pancreas
-
Zeba Ahmad, Ph.D.American Cancer Society, Inc.ReclutamentoCaregiving for CancerStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Institut Cancerologie de l'OuestAttivo, non reclutanteQualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer CenterFrancia
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
NRG OncologyNational Cancer Institute (NCI)CompletatoCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea del Sud
-
Jonsson Comprehensive Cancer CenterReclutamentoAdenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsReclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Second Affiliated Hospital, School of Medicine,...Attivo, non reclutanteElettroacopuntura combinata con paclitaxel legato alla proteina e anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric CancerCina