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Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas
This study is ongoing, but not recruiting participants.
First Received: January 9, 2004   Last Updated: February 6, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075686
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Biological: cetuximab
Drug: gemcitabine hydrochloride
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Cetuximab Ultrase
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival comparison between treatment groups [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate comparison between treatment groups as measured by RECIST and radiological evaluation at every other course [ Designated as safety issue: No ]
  • Time to treatment failure comparison between groups from registration to first observation of progressive disease, symptomatic deterioration, or death [ Designated as safety issue: No ]
  • Percentage of patients with EGFR tumor expression and compare overall survival of patients in the EGFR subset [ Designated as safety issue: No ]
  • Toxicity profile comparison of patients treated with 2 regimens and measured until 30 days after completion of study treatment [ Designated as safety issue: Yes ]
  • Total response rate comparison between treatment groups in the subset of patients with measurable disease by RECIST at every other course [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Study Start Date: January 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075686

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site

Publications:
Philip PA, Benedetti J, Fenoglio-Preiser C, et al.: Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA4509, 2007.

Study ID Numbers: CDR0000347414, SWOG-S0205, CALGB-S0205, CAN-NCIC-PAC1
Study First Received: January 9, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00075686     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Pancrelipase
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
 Cetuximab
Gastrointestinal Agents
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009



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