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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075686
• Other study ID #: CDR0000347414
• Secondary ID: S0205CALGB-S0205
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2004
• Last updated: November 16, 2015
• Start date: January 2004
• Est. completion date: April 2009

Study information

• Verified date: November 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 766
• Est. completion date: April 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:

• Locally advanced unresectable disease

• Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer

• Measurable or nonmeasurable disease by x-ray, scan, or physical examination

• Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry

• None of the following tumor types are allowed:

• Endocrine tumors

• Lymphoma of the pancreas

• Ampullary cancer

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 2.0 times upper limit of normal (ULN)

• SGOT or SGPT no greater than 2.5 times ULN

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No significant history of cardiac disease

• No uncontrolled hypertension

• No unstable angina

• No uncontrolled arrhythmia

• No congestive heart failure

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy for advanced pancreatic cancer

• No prior cetuximab or other therapy that targets the epidermal growth factor pathway

• No prior chimerized or murine monoclonal antibody therapy

• No other concurrent anticancer immunotherapy

Chemotherapy

• At least 6 months since prior adjuvant chemotherapy

• No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer

• No prior gemcitabine

• No other concurrent anticancer chemotherapy

Endocrine therapy

• No prior hormonal therapy for advanced pancreatic cancer

• No concurrent anticancer hormonal therapy

Radiotherapy

• See Chemotherapy

• At least 28 days since prior radiotherapy and recovered

• Prior palliative radiotherapy to metastatic sites allowed

• No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis)

Surgery

• At least 14 days since prior pancreatic cancer surgery and recovered

Other

• No other concurrent anticancer therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• cetuximab
Loading dose: Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only). Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cycles

Drug:
• gemcitabine hydrochloride
1000mg/m2 IV over 30 minutes

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital of Barrie	Barrie	Ontario
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Trillium Health Centre - Mississauga Site	Mississauga	Ontario
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	St. Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Akron City Hospital	Akron	Ohio
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	New York Oncology Hematology, PC - Albany	Albany	New York
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	Harrington Cancer Center	Amarillo	Texas
United States	American Fork Hospital	American Fork	Utah
United States	McFarland Clinic, P. C.	Ames	Iowa
United States	Alaska Regional Hospital Cancer Center	Anchorage	Alaska
United States	Cancer Center at Providence Alaska Medical Center	Anchorage	Alaska
United States	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Fox Valley Hematology and Oncology - East Grant Street	Appleton	Wisconsin
United States	Randolph Hospital	Asheboro	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Cancer Care at Our Lady of Bellefonte Hospital	Ashland	Kentucky
United States	Sturdy Memorial Hospital	Attleboro	Massachusetts
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	St. Joseph Hospital Community Cancer Center	Bellingham	Washington
United States	St. Charles Medical Center - Bend	Bend	Oregon
United States	Green Mountain Oncology Group	Bennington	Vermont
United States	Southwestern Vermont Regional Cancer Center	Bennington	Vermont
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Deaconess Billings Clinic Cancer Center	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare	Billings	Montana
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center	Boca Raton	Florida
United States	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho
United States	Cancer Center of Boston - Chestnut Hill	Boston	Massachusetts
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Internal Medicine Associates of Bozeman	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Peninsula Medical Center	Burlingame	California
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	St. James Community Hospital	Butte	Montana
United States	Graham Hospital	Canton	Illinois
United States	University Hospitals Ireland Cancer Center at Mercy Medical Center	Canton	Ohio
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Providence Centralia Hospital Regional Cancer Center	Centralia	Washington
United States	Cancer Center of Kansas, P.A. - Chanute	Chanute	Kansas
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Martha Jefferson Hospital Cancer Care Center	Charlottesville	Virginia
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	United Hospital Center	Clarksburg	West Virginia
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Euclid Hospital	Cleveland	Ohio
United States	Huron Hospital Cancer Care Center	Cleveland	Ohio
United States	Memorial Hospital	Colorado Springs	Colorado
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Riverside Cancer Services	Columbus	Ohio
United States	John B. Amos Community Cancer Center	Columbus	Georgia
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Mount Diablo Regional Cancer Center	Concord	California
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Heartland Oncology & Hematology	Council Bluffs	Iowa
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Praxair Cancer Center at Danbury Hospital	Danbury	Connecticut
United States	Danville Regional Medical Center	Danville	Virginia
United States	Genesis Medical Center - West Campus	Davenport	Iowa
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Halifax Medical Center	Daytona Beach	Florida
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas, P.A. - Dodge City	Dodge City	Kansas
United States	Seacoast Cancer Center at Wentworth-Douglass Hospital	Dover	New Hampshire
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center	Dubois	Pennsylvania
United States	Easton Regional Cancer Center at Easton Hospital	Easton	Pennsylvania
United States	Luther Midlelfort Hospital	Eau Claire	Wisconsin
United States	Midelfort Clinic - Luther	Eau Claire	Wisconsin
United States	John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital	Eden	North Carolina
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Center for Cancer Medicine and Blood Disorders, PA	El Paso	Texas
United States	Sherman Hospital	Elgin	Illinois
United States	Vince Lombardi Cancer Center - Elkhorn	Elkhorn	Wisconsin
United States	Eureka Community Hospital	Eureka	Illinois
United States	San Juan Regional Cancer Center	Farmington	New Mexico
United States	St. Francis Hospital	Federal Way	Washington
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	California Cancer Center - Woodward Park Office	Fresno	California
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Broward General Medical Center Cancer Center	Ft. Lauderdale	Florida
United States	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Ft. Smith	Arkansas
United States	Virginia K. Crosson Cancer Center at St. Jude Medical Center	Fullerton	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois
United States	Medical and Surgical Specialists, L L C	Galesburg	Illinois
United States	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri
United States	Delnor Community Hospital - Geneva	Geneva	Illinois
United States	Banner Thunderbird Medical Center	Glendale	Arizona
United States	Adirondack Cancer Care - Glens Falls	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Mercy Medical Center	Grand Rapids	Michigan
United States	Metropolitan Hospital	Grand Rapids	Michigan
United States	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan
United States	Big Sky Oncology	Great Falls	Montana
United States	Sletten Regional Cancer Institute	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Marin Cancer Institute at Marin General Hospital	Greenbrae	California
United States	Sutter Health Western Division Cancer Research Group	Greenbrae	California
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Mason District Hospital	Havana	Illinois
United States	Saint Rose Hospital	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Holland Community Hospital	Holland	Michigan
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Borgess Medical Center	Kalamazooaa	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Good Samaritan Health Systems	Kearney	Nebraska
United States	Kenton Oncology, Incorporated	Kenton	Ohio
United States	Keesler Medical Center - Keesler Air Force Base	Kessler AFB	Mississippi
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas, P.A. - Kingman	Kingman	Kansas
United States	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	La Grange Memorial Hospital	La Grange	Illinois
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Haematology-Oncology Associates of Ohio and Michigan, P.C.	Lambertville	Michigan
United States	Fairfield Medical Center	Lancaster	Ohio
United States	St. Mary Regional Cancer Center	Langhorne	Pennsylvania
United States	New York Oncology Hematology, P.C.	Latham	New York
United States	Central Maine Medical Center	Lewiston	Maine
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Southwest Medical Center	Liberal	Kansas
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Logan Regional Hospital	Logan	Utah
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	McKee Medical Center	Loveland	Colorado
United States	UMC Southwest Cancer and Research Center	Lubbock	Texas
United States	McDonough District Hospital	Macomb	Illinois
United States	Medical Center of Central Georgia	Macon	Georgia
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Upper Michigan Cancer Center at Marquette General Hospital	Marquette	Michigan
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Caritas Holy Family Hospital	Methuen	Massachusetts
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	MidMichigan Medical Center - Midland	Midland	Michigan
United States	Eastern Montana Cancer Center	Miles City	Montana
United States	Medical Consultants, Limited	Milwaukee	Wisconsin
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Community Medical Center	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital System	Monroe	Michigan
United States	Montrose Memorial Hospital Cancer Center	Montrose	Colorado
United States	Good Samaritan Regional Health Center	Mt. Vernon	Illinois
United States	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Hackley Hospital	Muskegon	Michigan
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas, P.A. - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Southwest Virginia Regional Cancer Center	Norton	Virginia
United States	Caritas Norwood Hospital	Norwood	Massachusetts
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital at St. George's University School of Medicine	Oakland	California
United States	Summit Medical Center	Oakland	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Capital Medical Center	Olympia	Washington
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	East Alabama Medical Center	Opelika	Alabama
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Florida Oncology Associates	Orange Park	Florida
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois
United States	Ottumwa Regional Health Center Cancer Center	Ottumwa	Iowa
United States	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	West Florida Cancer Institute at West Florida Hospital - Pensacola	Pensacola	Florida
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Mount Carmel Regional Cancer Center	Pittsburg	Kansas
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Valley Care Medical Center	Pleasanton	California
United States	St. Joseph Mercy Hospital	Pontiac	Michigan
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Institute of Oncology at Vilnius University	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center	Portland	Oregon
United States	Mercy Hospital	Portland	Maine
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Cancer Center of Kansas, P.A. - Pratt	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	All Saints Cancer Center at All Saints Medical Center	Racine	Wisconsin
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana
United States	Valley Hospital - Ridgewood	Ridgewood	New Jersey
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Mercy General Hospital	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Salem Hospital Regional Cancer Center	Salem	Oregon
United States	Cancer Center of Kansas, P.A. - Salina	Salina	Kansas
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	J.C. Robinson, M.D. Regional Cancer Center	San Pablo	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Cancer Treatment Center at Christus Schumpert St. Mary Place	Shreveport	Louisiana
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Providence Cancer Center at Holy Family Hospital	Spokane	Washington
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	Rockwood Clinic Cancer Treatment Center	Spokane	Washington
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Highlands Oncology Group - Springdale	Springdale	Arkansas
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Mercy Medical Center	Springfield	Ohio
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri
United States	St. Anthony's Cancer Center	St. Louis	Missouri
United States	Park Nicollet Health Services	St. Louis Park	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Carl and Dorothy Bennett Cancer Center at Stamford Hospital	Stamford	Connecticut
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio
United States	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York
United States	St. Joseph's Hospital Health Center - Syracuse	Syracuse	New York
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical College of Ohio Cancer Institute	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Toledo Surgical Specialists	Toledo	Ohio
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	Stormont-Vail Cancer Center	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Faxton Regional Cancer Center	Utica	New York
United States	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia
United States	Sutter Solano Medical Center	Vallejo	California
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	South Pointe Hospital Cancer Care Center	Warrensville Heights	Ohio
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Cedar Valley Medical Specialists, P.C. - West Ridgeway Avenue	Waterloo	Iowa
United States	Covenant Cancer Treatment Center	Waterloo	Iowa
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, P.A. - Wellington	Wellington	Kansas
United States	Wenatchee Valley Clinic	Wenatchee	Washington
United States	Jennersville Regional Hospital	West Grove	Pennsylvania
United States	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital	Whittier	California
United States	Associates in Womens Health, P.A. - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Wilson Medical Center	Wilson	North Carolina
United States	Cancer Center of Kansas, P.A. - Winfield	Winfield	Kansas
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	United States Air Force Medical Center Wright-Patterson	Wright-Patterson Afb	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	Tod Children's Hospital - Forum Health	Youngstown	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Southwest Oncology Group	Canadian Cancer Trials Group, Cancer and Leukemia Group B, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival comparison between treatment groups		every 4 weeks for 3 years	No
Secondary	Response rate comparison between treatment groups as measured by RECIST and radiological evaluation at every other course		every 9 weeks until progression	No
Secondary	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	No
Secondary	Percentage of patients with EGFR tumor expression and compare overall survival of patients in the EGFR subset		every 4 weeks for 3 years	No
Secondary	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	Yes
Secondary	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	No
Secondary	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		every 4 weeks while on treatment	No