S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer

November 16, 2015 updated by: Southwest Oncology Group

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas.

Study Overview

Status

Completed

Conditions

Pancreatic Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Compare the overall survival of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with gemcitabine and cetuximab vs gemcitabine alone.
Compare the time to treatment failure in patients treated with these regimens.
Estimate the percentage of patients with epidermal growth factor receptor (EGFR) tumor expression in patients treated with these regimens.
Compare the overall survival of patients in the EGFR-positive subset treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare the total response rate (confirmed and unconfirmed complete and partial response) in patients with measurable disease treated with these regimens.
Compare the patient report of pain and quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to disease status (locally advanced unresectable vs metastatic), Zubrod performance status (0 or 1 vs 2), and prior pancreatectomy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22 and gemcitabine IV over 30 minutes on days 1, 8, 15, and 22 for course 1 and days 1, 8, and 15 for all subsequent courses.
Arm II: Patients receive gemcitabine as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the end of study therapy.

Patients are followed every 6 months for 2 years and then annually for 1 year.

PROJECTED ACCRUAL: A total of 704 patients (352 per treatment arm) will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Actual)

766

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V8
    - Nova Scotia Cancer Centre
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Royal Victoria Hospital of Barrie
  - Mississauga, Ontario, Canada, L5B 1B8
    - Trillium Health Centre - Mississauga Site
  - Toronto, Ontario, Canada, M6R 1B5
    - St. Joseph's Health Centre - Toronto
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
United States
- Alabama
  - Mobile, Alabama, United States, 36652-2144
    - Mobile Infirmary Medical Center
  - Opelika, Alabama, United States, 36801-5452
    - East Alabama Medical Center
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Regional Hospital Cancer Center
  - Anchorage, Alaska, United States, 99519-6604
    - Cancer Center at Providence Alaska Medical Center
- Arizona
  - Glendale, Arizona, United States, 85306
    - Banner Thunderbird Medical Center
  - Phoenix, Arizona, United States, 85006
    - Banner Good Samaritan Medical Center
  - Phoenix, Arizona, United States, 85006
    - CCOP - Western Regional, Arizona
- Arkansas
  - Ft. Smith, Arkansas, United States, 72903
    - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  - Springdale, Arkansas, United States, 72764
    - Highlands Oncology Group - Springdale
- California
  - Berkeley, California, United States, 94704
    - Alta Bates Comprehensive Cancer Center
  - Burlingame, California, United States, 94010
    - Peninsula Medical Center
  - Concord, California, United States, 94524-4110
    - Mount Diablo Regional Cancer Center
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fresno, California, United States, 93720
    - California Cancer Center - Woodward Park Office
  - Fullerton, California, United States, 92835
    - Virginia K. Crosson Cancer Center at St. Jude Medical Center
  - Greenbrae, California, United States, 94904
    - Sutter Health Western Division Cancer Research Group
  - Greenbrae, California, United States, 94904
    - Marin Cancer Institute at Marin General Hospital
  - Hayward, California, United States, 94545
    - Saint Rose Hospital
  - Loma Linda, California, United States, 92354
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Summit Medical Center
  - Oakland, California, United States, 94602
    - Highland General Hospital at St. George's University School of Medicine
  - Orange, California, United States, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  - Pleasanton, California, United States, 94588
    - Valley Care Medical Center
  - Sacramento, California, United States, 95819
    - Mercy General Hospital
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Pablo, California, United States, 94806
    - J.C. Robinson, M.D. Regional Cancer Center
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
  - Walnut Creek, California, United States, 94598
    - John Muir/Mt. Diablo Comprehensive Cancer Center
  - Whittier, California, United States, 90602
    - Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital
  - Denver, Colorado, United States, 80220
    - Veterans Affairs Medical Center - Denver
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80524
    - Front Range Cancer Specialists
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Montrose, Colorado, United States, 81401
    - Montrose Memorial Hospital Cancer Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Praxair Cancer Center at Danbury Hospital
  - Stamford, Connecticut, United States, 06904
    - Carl and Dorothy Bennett Cancer Center at Stamford Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Boca Raton, Florida, United States, 33486
    - Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
  - Daytona Beach, Florida, United States, 32115
    - Halifax Medical Center
  - Ft. Lauderdale, Florida, United States, 33316
    - Broward General Medical Center Cancer Center
  - Gainesville, Florida, United States, 32610-0232
    - University of Florida Shands Cancer Center
  - Orange Park, Florida, United States, 32073
    - Florida Oncology Associates
  - Orlando, Florida, United States, 32803-1273
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Pensacola, Florida, United States, 32514
    - West Florida Cancer Institute at West Florida Hospital - Pensacola
- Georgia
  - Columbus, Georgia, United States, 31904
    - John B. Amos Community Cancer Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Macon, Georgia, United States, 31208
    - Medical Center of Central Georgia
  - Savannah, Georgia, United States, 31403-3089
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Valdosta, Georgia, United States, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Idaho
  - Boise, Idaho, United States, 83712
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60507
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, United States, 60120
    - Sherman Hospital
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic
  - Galesburg, Illinois, United States, 61401
    - Medical and Surgical Specialists, L L C
  - Galesburg, Illinois, United States, 61401
    - InterCommunity Cancer Center of Western Illinois
  - Geneva, Illinois, United States, 60134
    - Delnor Community Hospital - Geneva
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates
  - Hopedale, Illinois, United States, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology Hematology Associates, Limited - West
  - Kewanee, Illinois, United States, 61443
    - Kewanee Hospital
  - La Grange, Illinois, United States, 60525
    - La Grange Memorial Hospital
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Mt. Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Olympia Fields, Illinois, United States, 60461
    - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology/Hematology Associates of Central Illinois, P.C.
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, United States, 61362
    - St. Margaret's Hospital
  - Spring Valley, Illinois, United States, 61362
    - Valley Cancer Center
  - Springfield, Illinois, United States, 62781
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Fort Wayne, Indiana, United States, 46815
    - Fort Wayne Medical Oncology and Hematology
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services, Incorporated
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, P. C.
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, United States, 52402
    - St. Luke's Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Council Bluffs, Iowa, United States, 51503
    - Heartland Oncology & Hematology
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Ottumwa, Iowa, United States, 52501
    - Ottumwa Regional Health Center Cancer Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
  - Waterloo, Iowa, United States, 50702
    - Covenant Cancer Treatment Center
  - Waterloo, Iowa, United States, 50702
    - Cedar Valley Medical Specialists, P.C. - West Ridgeway Avenue
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, P.A. - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, P.A. - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, P.A. - El Dorado
  - Kansas City, Kansas, United States, 66160-7357
    - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, P.A. - Kingman
  - Liberal, Kansas, United States, 67901
    - Southwest Medical Center
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, P.A. - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, P.A. - Parsons
  - Pittsburg, Kansas, United States, 66762
    - Mount Carmel Regional Cancer Center
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, P.A. - Pratt
  - Salina, Kansas, United States, 67042
    - Cancer Center of Kansas, P.A. - Salina
  - Topeka, Kansas, United States, 66606
    - St. Francis Comprehensive Cancer Center
  - Topeka, Kansas, United States, 66604
    - Stormont-Vail Cancer Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, P.A. - Wellington
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, P.A. - Wichita
  - Wichita, Kansas, United States, 67203
    - Associates in Womens Health, P.A. - North Review
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, P.A. - Medical Arts Tower
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, P.A. - Winfield
- Kentucky
  - Ashland, Kentucky, United States, 41101
    - Cancer Care at Our Lady of Bellefonte Hospital
  - Lexington, Kentucky, United States, 40503-9985
    - Central Baptist Hospital
- Louisiana
  - Shreveport, Louisiana, United States, 71101
    - Cancer Treatment Center at Christus Schumpert St. Mary Place
- Maine
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center
  - Portland, Maine, United States, 04101
    - Mercy Hospital
- Massachusetts
  - Attleboro, Massachusetts, United States, 02703
    - Sturdy Memorial Hospital
  - Boston, Massachusetts, United States, 02118
    - Cancer Research Center at Boston Medical Center
  - Boston, Massachusetts, United States, 02135-2997
    - Caritas St. Elizabeth's Medical Center
  - Boston, Massachusetts, United States, 02120
    - Cancer Center of Boston - Chestnut Hill
  - Methuen, Massachusetts, United States, 01844
    - Caritas Holy Family Hospital
  - Norwood, Massachusetts, United States, 02062
    - Caritas Norwood Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Mercy Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health Cancer Care - Butterworth Campus
  - Grand Rapids, Michigan, United States, 49506
    - Metropolitan Hospital
  - Holland, Michigan, United States, 49423
    - Holland Community Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Kalamazooaa, Michigan, United States, 49001
    - Borgess Medical Center
  - Lambertville, Michigan, United States, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, P.C.
  - Marquette, Michigan, United States, 49855
    - Upper Michigan Cancer Center at Marquette General Hospital
  - Midland, Michigan, United States, 48670
    - MidMichigan Medical Center - Midland
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital System
  - Muskegon, Michigan, United States, 49443
    - Hackley Hospital
  - Petoskey, Michigan, United States, 49770
    - Northern Michigan Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - St. Louis Park, Minnesota, United States, 55416
    - Park Nicollet Health Services
  - St. Paul, Minnesota, United States, 55102
    - United Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
- Mississippi
  - Jackson, Mississippi, United States, 39216-4505
    - University of Mississippi Medical Center
  - Kessler AFB, Mississippi, United States, 39534
    - Keesler Medical Center - Keesler Air Force Base
- Missouri
  - Cape Girardeau, Missouri, United States, 63701
    - Saint Francis Medical Center
  - Gape Girardeau, Missouri, United States, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - St. Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - St. Louis, Missouri, United States, 63128
    - St. Anthony's Cancer Center
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare
  - Billings, Montana, United States, 59107-7000
    - Deaconess Billings Clinic - Downtown
  - Billings, Montana, United States, 59107-5100
    - Deaconess Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Bozeman, Montana, United States, 59715
    - Internal Medicine Associates of Bozeman
  - Butte, Montana, United States, 59701
    - St. James Community Hospital
  - Great Falls, Montana, United States, 59405
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Regional Cancer Institute
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Miles City, Montana, United States, 59301
    - Eastern Montana Cancer Center
  - Missoula, Montana, United States, 59801
    - Community Medical Center
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, United States, 68848-1990
    - Good Samaritan Health Systems
  - Omaha, Nebraska, United States, 68114
    - Methodist Cancer Center at Methodist Hospital - Omaha
- New Hampshire
  - Dover, New Hampshire, United States, 03820
    - Seacoast Cancer Center at Wentworth-Douglass Hospital
- New Jersey
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital - Ridgewood
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Research and Treatment Center
  - Farmington, New Mexico, United States, 87401-5631
    - San Juan Regional Cancer Center
- New York
  - Albany, New York, United States, 12208
    - New York Oncology Hematology, PC - Albany
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Glens Falls, New York, United States, 12801
    - Adirondack Cancer Care - Glens Falls
  - Latham, New York, United States, 12110
    - New York Oncology Hematology, P.C.
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - New Hyde Park, New York, United States, 11042
    - Long Island Jewish Medical Center
  - Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Syracuse, New York, United States, 13203
    - St. Joseph's Hospital Health Center - Syracuse
  - Utica, New York, United States, 13502
    - Faxton Regional Cancer Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203-5400
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28801
    - Mission Hospitals - Memorial Campus
  - Charlotte, North Carolina, United States, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Eden, North Carolina, United States, 27288
    - John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Radiation Oncology
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Greensboro, North Carolina, United States, 27403-1199
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - Kinston, North Carolina, United States, 28501
    - Lenoir Memorial Cancer Center
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Cancer Center
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Wilson, North Carolina, United States, 27893-3428
    - Wilson Medical Center
  - Winston-Salem, North Carolina, United States, 27103
    - Forsyth Regional Cancer Center at Forsyth Medical Center
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Akron, Ohio, United States, 44309-2090
    - Akron City Hospital
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Canton, Ohio, United States, 44708
    - University Hospitals Ireland Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44112
    - Huron Hospital Cancer Care Center
  - Cleveland, Ohio, United States, 44119
    - Euclid Hospital
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Columbus, Ohio, United States, 43215
    - Grant Riverside Cancer Services
  - Columbus, Ohio, United States, 43222
    - Mount Carmel West Hospital
  - Dayton, Ohio, United States, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45429
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Fremont, Ohio, United States, 43420
    - Fremont Memorial Hospital
  - Independence, Ohio, United States, 44131
    - Community Oncology Group at Cleveland Clinic Cancer Center
  - Kenton, Ohio, United States, 43326
    - Kenton Oncology, Incorporated
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, United States, 45801
    - St. Rita's Medical Center
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, United States, 43537
    - St. Luke's Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Middletown, Ohio, United States, 45044
    - Middletown Regional Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, United States, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, United States, 45504
    - Mercy Medical Center
  - Sylvania, Ohio, United States, 43560
    - Promedica Cancer Center at Flower Hospital
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43614
    - Medical College of Ohio Cancer Institute
  - Toledo, Ohio, United States, 43623
    - Toledo Surgical Specialists
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Warrensville Heights, Ohio, United States, 44122
    - South Pointe Hospital Cancer Care Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic - Wooster
  - Wright-Patterson Afb, Ohio, United States, 45433-5529
    - United States Air Force Medical Center Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Youngstown, Ohio, United States, 44501
    - Tod Children's Hospital - Forum Health
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Bend, Oregon, United States, 97701
    - St. Charles Medical Center - Bend
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Institute of Oncology at Vilnius University
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  - Salem, Oregon, United States, 97309-5014
    - Salem Hospital Regional Cancer Center
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Hospital Cancer Center
  - Dubois, Pennsylvania, United States, 15801
    - Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center
  - Easton, Pennsylvania, United States, 18042
    - Easton Regional Cancer Center at Easton Hospital
  - Langhorne, Pennsylvania, United States, 19047
    - St. Mary Regional Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny Cancer Center at Allegheny General Hospital
  - Reading, Pennsylvania, United States, 19612-6052
    - Reading Hospital and Medical Center
  - West Grove, Pennsylvania, United States, 19390-9499
    - Jennersville Regional Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Rose Ramer Cancer Clinic at Anderson Area Medical Center
  - Charleston, South Carolina, United States, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston, South Carolina, United States, 29401
    - Roper St. Francis Cancer Center at Roper Hospital
  - Florence, South Carolina, United States, 29501
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, United States, 29601
    - Bon Secours St. Francis Health System
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sioux Valley Hospital and University of South Dakota Medical Center
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center, PC
- Tennessee
  - Kingsport, Tennessee, United States, 37662
    - Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  - Knoxville, Tennessee, United States, 37916
    - Thompson Cancer Survival Center
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Dallas, Texas, United States, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, United States, 75231
    - Presbyterian Hospital of Dallas
  - El Paso, Texas, United States, 79902
    - Center for Cancer Medicine and Blood Disorders, PA
  - Fort Sam Houston, Texas, United States, 78234
    - Brooke Army Medical Center
  - Houston, Texas, United States, 77030
    - Baylor University Medical Center - Houston
  - Houston, Texas, United States, 77030-4009
    - M.D. Anderson Cancer Center at University of Texas
  - Lackland AFB, Texas, United States, 78236
    - Wilford Hall Medical Center
  - Lubbock, Texas, United States, 79415-3364
    - UMC Southwest Cancer and Research Center
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84107
    - Cottonwood Hospital Medical Center
  - Ogden, Utah, United States, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Bennington, Vermont, United States, 05201
    - Green Mountain Oncology Group
  - Bennington, Vermont, United States, 05201
    - Southwestern Vermont Regional Cancer Center
- Virginia
  - Charlottesville, Virginia, United States, 22901
    - Martha Jefferson Hospital Cancer Care Center
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Norton, Virginia, United States, 24273
    - Southwest Virginia Regional Cancer Center
- Washington
  - Auburn, Washington, United States, 98002
    - Auburn Regional Center for Cancer Care
  - Bellingham, Washington, United States, 98225
    - St. Joseph Hospital Community Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Centralia, Washington, United States, 98531-9027
    - Providence Centralia Hospital Regional Cancer Center
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Mt. Vernon, Washington, United States, 98273
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, United States, 98507
    - Capital Medical Center
  - Olympia, Washington, United States, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98195-6043
    - University Cancer Center at University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98114
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Sedro-Wooley, Washington, United States, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99204-2967
    - Rockwood Clinic Cancer Treatment Center
  - Spokane, Washington, United States, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - Spokane, Washington, United States, 99207
    - Providence Cancer Center at Holy Family Hospital
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Tacoma, Washington, United States, 98405-3004
    - St. Joseph Medical Center at Franciscan Health System
  - Vancouver, Washington, United States, 98668
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Clinic
- West Virginia
  - Clarksburg, West Virginia, United States, 26301
    - United Hospital Center
  - Parkersburg, West Virginia, United States, 26102
    - Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Wisconsin
  - Appleton, Wisconsin, United States, 54911-3496
    - Fox Valley Hematology and Oncology - East Grant Street
  - Eau Claire, Wisconsin, United States, 54703-1510
    - Midelfort Clinic - Luther
  - Eau Claire, Wisconsin, United States, 54702
    - Luther Midlelfort Hospital
  - Elkhorn, Wisconsin, United States, 53121
    - Vince Lombardi Cancer Center - Elkhorn
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Milwaukee, Wisconsin, United States, 53215
    - Medical Consultants, Limited
  - Racine, Wisconsin, United States, 53405
    - All Saints Cancer Center at All Saints Medical Center
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:
- Locally advanced unresectable disease
- Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer
Measurable or nonmeasurable disease by x-ray, scan, or physical examination
Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry
None of the following tumor types are allowed:
- Endocrine tumors
- Lymphoma of the pancreas
- Ampullary cancer
No known brain metastases

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Zubrod 0-2

Life expectancy

At least 3 months

Hematopoietic

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2.0 times upper limit of normal (ULN)
SGOT or SGPT no greater than 2.5 times ULN

Renal

Creatinine no greater than 2.0 mg/dL

Cardiovascular

No significant history of cardiac disease
No uncontrolled hypertension
No unstable angina
No uncontrolled arrhythmia
No congestive heart failure

Other

Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior immunotherapy for advanced pancreatic cancer
No prior cetuximab or other therapy that targets the epidermal growth factor pathway
No prior chimerized or murine monoclonal antibody therapy
No other concurrent anticancer immunotherapy

Chemotherapy

At least 6 months since prior adjuvant chemotherapy
No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer
No prior gemcitabine
No other concurrent anticancer chemotherapy

Endocrine therapy

No prior hormonal therapy for advanced pancreatic cancer
No concurrent anticancer hormonal therapy

Radiotherapy

See Chemotherapy
At least 28 days since prior radiotherapy and recovered
Prior palliative radiotherapy to metastatic sites allowed
No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis)

Surgery

At least 14 days since prior pancreatic cancer surgery and recovered

Other

No other concurrent anticancer therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gemcitabine hydrochloride + IMC-C225 Loading dose: gemcitabine hydrochloride 1000mg/m2, IV on Day 1; Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only) Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cycles; gemcitabine hydrochloride 1000mg/m2, IV on Days 8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.	Biological: cetuximab Loading dose: Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only). Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cycles Drug: gemcitabine hydrochloride 1000mg/m2 IV over 30 minutes
Experimental: gemcitabine hydrochloride alone gemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.	Drug: gemcitabine hydrochloride 1000mg/m2 IV over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival comparison between treatment groups Time Frame: every 4 weeks for 3 years	every 4 weeks for 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate comparison between treatment groups as measured by RECIST and radiological evaluation at every other course Time Frame: every 9 weeks until progression	every 9 weeks until progression
Time to treatment failure comparison between groups from registration to first observation of progressive disease, symptomatic deterioration, or death Time Frame: every 4 weeks while on treatment	every 4 weeks while on treatment
Percentage of patients with EGFR tumor expression and compare overall survival of patients in the EGFR subset Time Frame: every 4 weeks for 3 years	every 4 weeks for 3 years
Toxicity profile comparison of patients treated with 2 regimens and measured until 30 days after completion of study treatment Time Frame: every 4 weeks while on treatment	every 4 weeks while on treatment
Total response rate comparison between treatment groups in the subset of patients with measurable disease by RECIST at every other course Time Frame: every 9 weeks until progression	every 9 weeks until progression
Pain and quality of life comparison between treatment groups as measured by patient questionnaire at baseline, before each course, and then completion of study treatment Time Frame: every 4 weeks while on treatment	every 4 weeks while on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Cancer and Leukemia Group B

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 12, 2004

First Posted (Estimate)

January 13, 2004

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000347414
U10CA032102 (U.S. NIH Grant/Contract)
S0205 (Other Identifier: SWOG)
CALGB-S0205 (Other Identifier: CALGB)
CAN-NCIC-PAC1 (Other Identifier: NCIC-CTG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Pancreatic Cancer

Clinical Trials on cetuximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations