AzTrials
AzTrials

Pancreatic CancerPhase 3NCT00075686

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

A Phase 3 study testing cetuximab and gemcitabine hydrochloride in people with Pancreatic Cancer, run by SWOG Cancer Research Network at 389 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
cetuximab and gemcitabine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
389 sitesin 2 countries
Study dates
Jan 2004to Apr 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

389 sites in 2 countries.

307 sites in 2 countries

United States300 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC - Albany

    Albany, New York, 12208

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

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

    Alton, Illinois, 62002

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, P. C.

    Ames, Iowa, 50010

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Cancer Center at Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Fox Valley Hematology and Oncology - East Grant Street

    Appleton, Wisconsin, 54911-3496

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Cancer Care at Our Lady of Bellefonte Hospital

    Ashland, Kentucky, 41101

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

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

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • St. Charles Medical Center - Bend

    Bend, Oregon, 97701

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

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

    Boca Raton, Florida, 33486

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Cancer Center of Boston - Chestnut Hill

    Boston, Massachusetts, 02120

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135-2997

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Community Hospital

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • University Hospitals Ireland Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Memorial Hospital

    Carthage, Illinois, 62321

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital Regional Cancer Center

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, P.A. - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Martha Jefferson Hospital Cancer Care Center

    Charlottesville, Virginia, 22901

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • United Hospital Center

    Clarksburg, West Virginia, 26301

  • Huron Hospital Cancer Care Center

    Cleveland, Ohio, 44112

  • Euclid Hospital

    Cleveland, Ohio, 44119

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • John B. Amos Community Cancer Center

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mount Diablo Regional Cancer Center

    Concord, California, 94524-4110

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Heartland Oncology & Hematology

    Council Bluffs, Iowa, 51503

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Halifax Medical Center

    Daytona Beach, Florida, 32115

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

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

    Dodge City, Kansas, 67801

  • Seacoast Cancer Center at Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

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

    DuBois, Pennsylvania, 15801

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Luther Midlelfort Hospital

    Eau Claire, Wisconsin, 54702

  • Midelfort Clinic - Luther

    Eau Claire, Wisconsin, 54703-1510

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

    Eden, North Carolina, 27288

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

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

    El Dorado, Kansas, 67042

  • Center for Cancer Medicine and Blood Disorders, PA

    El Paso, Texas, 79902

  • Sherman Hospital

    Elgin, Illinois, 60120

  • Vince Lombardi Cancer Center - Elkhorn

    Elkhorn, Wisconsin, 53121

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • San Juan Regional Cancer Center

    Farmington, New Mexico, 87401-5631

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

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

    Fullerton, California, 92835

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Medical and Surgical Specialists, L L C

    Galesburg, Illinois, 61401

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Delnor Community Hospital - Geneva

    Geneva, Illinois, 60134

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Adirondack Cancer Care - Glens Falls

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1199

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Mason District Hospital

    Havana, Illinois, 62644

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazooaa, Michigan, 49001

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

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

    Kansas City, Kansas, 66160-7357

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Health Systems

    Kearney, Nebraska, 68848-1990

  • Kenton Oncology, Incorporated

    Kenton, Ohio, 43326

  • Keesler Medical Center - Keesler Air Force Base

    Kessler Air Force Base, Mississippi, 39534

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, P.A. - Kingman

    Kingman, Kansas, 67068

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

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

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • St. Mary Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • New York Oncology Hematology, P.C.

    Latham, New York, 12110

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • McKee Medical Center

    Loveland, Colorado, 80539

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415-3364

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Upper Michigan Cancer Center at Marquette General Hospital

    Marquette, Michigan, 49855

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Medical Consultants, Limited

    Milwaukee, Wisconsin, 53215

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

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

    Missoula, Montana, 59807

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital System

    Monroe, Michigan, 48162

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11042

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas, P.A. - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Southwest Virginia Regional Cancer Center

    Norton, Virginia, 24273

  • Caritas Norwood Hospital

    Norwood, Massachusetts, 02062

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

    Oakland, California, 94602

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • Capital Medical Center

    Olympia, Washington, 98507

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

    Olympia Fields, Illinois, 60461

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • East Alabama Medical Center

    Opelika, Alabama, 36801-5452

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

    Orange, California, 92868

  • Florida Oncology Associates

    Orange Park, Florida, 32073

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Ottumwa Regional Health Center Cancer Center

    Ottumwa, Iowa, 52501

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • West Florida Cancer Institute at West Florida Hospital - Pensacola

    Pensacola, Florida, 32514

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

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

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006

  • Mount Carmel Regional Cancer Center

    Pittsburg, Kansas, 66762

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • St. Joseph Mercy Hospital

    Pontiac, Michigan, 48341-2985

  • Mercy Hospital

    Portland, Maine, 04101

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Cancer Center of Kansas, P.A. - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • All Saints Cancer Center at All Saints Medical Center

    Racine, Wisconsin, 53405

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana, 47374

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salem Hospital Regional Cancer Center

    Salem, Oregon, 97309-5014

  • Cancer Center of Kansas, P.A. - Salina

    Salina, Kansas, 67042

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

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

    San Pablo, California, 94806

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

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

    Savannah, Georgia, 31403-3089

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

Other trials in United States

Canada7 sites

  • Royal Victoria Hospital of Barrie

    Barrie, Ontario, L4M 6M2

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V8

  • Trillium Health Centre - Mississauga Site

    Mississauga, Ontario, L5B 1B8

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • St. Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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.

Read the 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.

Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 hydrochlorideDrug

    1000mg/m2 IV over 30 minutes

Study groups in NCT00075686
Study groupRoleWhat they receive
gemcitabine hydrochloride + IMC-C225ExperimentalLoading 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.
Receives: Biological: cetuximab; Drug: gemcitabine hydrochloride
gemcitabine hydrochloride aloneExperimentalgemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.
Receives: Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival comparison between treatment groups

    Measured: every 4 weeks for 3 years

Secondary outcomes (6)

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

    Measured: every 9 weeks until progression

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

    Measured: every 4 weeks while on treatment

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

    Measured: every 4 weeks for 3 years

  4. Toxicity profile comparison of patients treated with 2 regimens and measured until 30 days after completion of study treatment

    Measured: every 4 weeks while on treatment

  5. Total response rate comparison between treatment groups in the subset of patients with measurable disease by RECIST at every other course

    Measured: every 9 weeks until progression

  6. 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

    Measured: every 4 weeks while on treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionMay 2007
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075686
Sponsor's protocol ID
CDR0000347414
Other IDs
S0205, CALGB-S0205, CAN-NCIC-PAC1, U10CA032102
Status last verified
Nov 2015
First submitted
9 Jan 2004
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

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.

  • 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.

    PubMed 20606093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cetuximab and gemcitabine hydrochloride in people with Pancreatic Cancer, run by SWOG Cancer Research Network at 389 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 389 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival comparison between treatment groups (time frame: every 4 weeks for 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00075686, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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