NCT00075686

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
766

participants targeted

Target at P75+ for phase_3 pancreatic-cancer

Timeline
Completed

Started Jan 2004

Typical duration for phase_3 pancreatic-cancer

Geographic Reach
2 countries

389 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

January 9, 2004

Last Update Submit

November 16, 2015

Conditions

Keywords

adenocarcinoma of the pancreasstage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival comparison between treatment groups

    every 4 weeks for 3 years

Secondary Outcomes (6)

  • Response rate comparison between treatment groups as measured by RECIST and radiological evaluation at every other course

    every 9 weeks until progression

  • Time to treatment failure comparison between groups from registration to first observation of progressive disease, symptomatic deterioration, or death

    every 4 weeks while on treatment

  • Percentage of patients with EGFR tumor expression and compare overall survival of patients in the EGFR subset

    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

    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

    every 9 weeks until progression

  • +1 more secondary outcomes

Study Arms (2)

gemcitabine hydrochloride + IMC-C225

EXPERIMENTAL

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: cetuximabDrug: gemcitabine hydrochloride

gemcitabine hydrochloride alone

EXPERIMENTAL

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

Interventions

cetuximabBIOLOGICAL

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

gemcitabine hydrochloride + IMC-C225

1000mg/m2 IV over 30 minutes

gemcitabine hydrochloride + IMC-C225gemcitabine hydrochloride alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (389)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

East Alabama Medical Center

Opelika, Alabama, 36801-5452, United States

Location

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Cancer Center at Providence Alaska Medical Center

Anchorage, Alaska, 99519-6604, United States

Location

Banner Thunderbird Medical Center

Glendale, Arizona, 85306, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006, United States

Location

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, 72903, United States

Location

Highlands Oncology Group - Springdale

Springdale, Arkansas, 72764, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Mount Diablo Regional Cancer Center

Concord, California, 94524-4110, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

California Cancer Center - Woodward Park Office

Fresno, California, 93720, United States

Location

Virginia K. Crosson Cancer Center at St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Highland General Hospital at St. George's University School of Medicine

Oakland, California, 94602, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Summit Medical Center

Oakland, California, 94609, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Valley Care Medical Center

Pleasanton, California, 94588, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

J.C. Robinson, M.D. Regional Cancer Center

San Pablo, California, 94806, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, 94598, United States

Location

Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital

Whittier, California, 90602, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80524, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Praxair Cancer Center at Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

Boca Raton, Florida, 33486, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32115, United States

Location

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Florida Oncology Associates

Orange Park, Florida, 32073, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

West Florida Cancer Institute at West Florida Hospital - Pensacola

Pensacola, Florida, 32514, United States

Location

John B. Amos Community Cancer Center

Columbus, Georgia, 31904, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31208, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 31603, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Sherman Hospital

Elgin, Illinois, 60120, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, 61401, United States

Location

Medical and Surgical Specialists, L L C

Galesburg, Illinois, 61401, United States

Location

Delnor Community Hospital - Geneva

Geneva, Illinois, 60134, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

La Grange Memorial Hospital

La Grange, Illinois, 60525, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

Olympia Fields, Illinois, 60461, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46815, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, 47374, United States

Location

McFarland Clinic, P. C.

Ames, Iowa, 50010, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Heartland Oncology & Hematology

Council Bluffs, Iowa, 51503, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Genesis Medical Center - West Campus

Davenport, Iowa, 52804, United States

Location

Ottumwa Regional Health Center Cancer Center

Ottumwa, Iowa, 52501, United States

Location

Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center

Sioux City, Iowa, 51101, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cedar Valley Medical Specialists, P.C. - West Ridgeway Avenue

Waterloo, Iowa, 50702, United States

Location

Covenant Cancer Treatment Center

Waterloo, Iowa, 50702, United States

Location

Cancer Center of Kansas, P.A. - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, P.A. - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, 67042, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas, P.A. - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, P.A. - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Mount Carmel Regional Cancer Center

Pittsburg, Kansas, 66762, United States

Location

Cancer Center of Kansas, P.A. - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, P.A. - Salina

Salina, Kansas, 67042, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, P.A. - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, P.A. - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A. - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, P.A. - Winfield

Winfield, Kansas, 67156, United States

Location

Cancer Care at Our Lady of Bellefonte Hospital

Ashland, Kentucky, 41101, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503-9985, United States

Location

Cancer Treatment Center at Christus Schumpert St. Mary Place

Shreveport, Louisiana, 71101, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

Mercy Hospital

Portland, Maine, 04101, United States

Location

Sturdy Memorial Hospital

Attleboro, Massachusetts, 02703, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Cancer Center of Boston - Chestnut Hill

Boston, Massachusetts, 02120, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135-2997, United States

Location

Caritas Holy Family Hospital

Methuen, Massachusetts, 01844, United States

Location

Caritas Norwood Hospital

Norwood, Massachusetts, 02062, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, P.C.

Lambertville, Michigan, 48144, United States

Location

Upper Michigan Cancer Center at Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

MidMichigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital System

Monroe, Michigan, 48162, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Joseph Mercy Hospital

Pontiac, Michigan, 48341-2985, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler Air Force Base

Kessler Air Force Base, Mississippi, 39534, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

St. Anthony's Cancer Center

St Louis, Missouri, 63128, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Internal Medicine Associates of Bozeman

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Eastern Montana Cancer Center

Miles City, Montana, 59301, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Good Samaritan Health Systems

Kearney, Nebraska, 68848-1990, United States

Location

Methodist Cancer Center at Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

Seacoast Cancer Center at Wentworth-Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Valley Hospital - Ridgewood

Ridgewood, New Jersey, 07450, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

San Juan Regional Cancer Center

Farmington, New Mexico, 87401-5631, United States

Location

New York Oncology Hematology, PC - Albany

Albany, New York, 12208, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Adirondack Cancer Care - Glens Falls

Glens Falls, New York, 12801, United States

Location

New York Oncology Hematology, P.C.

Latham, New York, 12110, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11042, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, 13057, United States

Location

St. Joseph's Hospital Health Center - Syracuse

Syracuse, New York, 13203, United States

Location

Faxton Regional Cancer Center

Utica, New York, 13502, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203-5400, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital

Eden, North Carolina, 27288, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27403-1199, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Lenoir Memorial Cancer Center

Kinston, North Carolina, 28501, United States

Location

Annie Penn Cancer Center

Reidsville, North Carolina, 27320, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

University Hospitals Ireland Cancer Center at Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Huron Hospital Cancer Care Center

Cleveland, Ohio, 44112, United States

Location

Euclid Hospital

Cleveland, Ohio, 44119, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Kenton Oncology, Incorporated

Kenton, Ohio, 43326, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Mercy Medical Center

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Promedica Cancer Center at Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical College of Ohio Cancer Institute

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

Toledo Surgical Specialists

Toledo, Ohio, 43623, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

South Pointe Hospital Cancer Care Center

Warrensville Heights, Ohio, 44122, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

United States Air Force Medical Center Wright-Patterson

Wright-Patterson AFB, Ohio, 45433-5529, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

St. Charles Medical Center - Bend

Bend, Oregon, 97701, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Institute of Oncology at Vilnius University

Portland, Oregon, 97227, United States

Location

Salem Hospital Regional Cancer Center

Salem, Oregon, 97309-5014, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center

DuBois, Pennsylvania, 15801, United States

Location

Easton Regional Cancer Center at Easton Hospital

Easton, Pennsylvania, 18042, United States

Location

St. Mary Regional Cancer Center

Langhorne, Pennsylvania, 19047, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Jennersville Regional Hospital

West Grove, Pennsylvania, 19390-9499, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37662, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

Center for Cancer Medicine and Blood Disorders, PA

El Paso, Texas, 79902, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

UMC Southwest Cancer and Research Center

Lubbock, Texas, 79415-3364, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Southwestern Vermont Regional Cancer Center

Bennington, Vermont, 05201, United States

Location

Martha Jefferson Hospital Cancer Care Center

Charlottesville, Virginia, 22901, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Southwest Virginia Regional Cancer Center

Norton, Virginia, 24273, United States

Location

Auburn Regional Center for Cancer Care

Auburn, Washington, 98002, United States

Location

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Providence Centralia Hospital Regional Cancer Center

Centralia, Washington, 98531-9027, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Capital Medical Center

Olympia, Washington, 98507, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98114, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Rockwood Clinic Cancer Treatment Center

Spokane, Washington, 99204-2967, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99207, United States

Location

St. Joseph Medical Center at Franciscan Health System

Tacoma, Washington, 98405-3004, United States

Location

Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Wenatchee Valley Clinic

Wenatchee, Washington, 98801, United States

Location

United Hospital Center

Clarksburg, West Virginia, 26301, United States

Location

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

Fox Valley Hematology and Oncology - East Grant Street

Appleton, Wisconsin, 54911-3496, United States

Location

Luther Midlelfort Hospital

Eau Claire, Wisconsin, 54702, United States

Location

Midelfort Clinic - Luther

Eau Claire, Wisconsin, 54703-1510, United States

Location

Vince Lombardi Cancer Center - Elkhorn

Elkhorn, Wisconsin, 53121, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Medical Consultants, Limited

Milwaukee, Wisconsin, 53215, United States

Location

All Saints Cancer Center at All Saints Medical Center

Racine, Wisconsin, 53405, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V8, Canada

Location

Royal Victoria Hospital of Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

Trillium Health Centre - Mississauga Site

Mississauga, Ontario, L5B 1B8, Canada

Location

St. Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (2)

  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CetuximabGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 13, 2004

Study Start

January 1, 2004

Primary Completion

May 1, 2007

Study Completion

April 1, 2009

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations