S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria: Locally advanced unresectable disease Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer Measurable or nonmeasurable disease by x-ray, scan, or physical examination Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry None of the following tumor types are allowed: Endocrine tumors Lymphoma of the pancreas Ampullary cancer No known brain metastases PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-2 Life expectancy At least 3 months Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.0 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No significant history of cardiac disease No uncontrolled hypertension No unstable angina No uncontrolled arrhythmia No congestive heart failure Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for advanced pancreatic cancer No prior cetuximab or other therapy that targets the epidermal growth factor pathway No prior chimerized or murine monoclonal antibody therapy No other concurrent anticancer immunotherapy Chemotherapy At least 6 months since prior adjuvant chemotherapy No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer No prior gemcitabine No other concurrent anticancer chemotherapy Endocrine therapy No prior hormonal therapy for advanced pancreatic cancer No concurrent anticancer hormonal therapy Radiotherapy See Chemotherapy At least 28 days since prior radiotherapy and recovered Prior palliative radiotherapy to metastatic sites allowed No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis) Surgery At least 14 days since prior pancreatic cancer surgery and recovered Other No other concurrent anticancer therapy
Sites / Locations
- Mobile Infirmary Medical Center
- East Alabama Medical Center
- Alaska Regional Hospital Cancer Center
- Cancer Center at Providence Alaska Medical Center
- Banner Thunderbird Medical Center
- Banner Good Samaritan Medical Center
- CCOP - Western Regional, Arizona
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- Highlands Oncology Group - Springdale
- Alta Bates Comprehensive Cancer Center
- Peninsula Medical Center
- Mount Diablo Regional Cancer Center
- City of Hope Comprehensive Cancer Center
- California Cancer Center - Woodward Park Office
- Virginia K. Crosson Cancer Center at St. Jude Medical Center
- Marin Cancer Institute at Marin General Hospital
- Sutter Health Western Division Cancer Research Group
- Saint Rose Hospital
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Highland General Hospital at St. George's University School of Medicine
- CCOP - Bay Area Tumor Institute
- Summit Medical Center
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Valley Care Medical Center
- University of California Davis Cancer Center
- Mercy General Hospital
- California Pacific Medical Center - California Campus
- J.C. Robinson, M.D. Regional Cancer Center
- Sutter Solano Medical Center
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Memorial Hospital
- Veterans Affairs Medical Center - Denver
- Front Range Cancer Specialists
- Poudre Valley Hospital
- North Colorado Medical Center
- McKee Medical Center
- Montrose Memorial Hospital Cancer Center
- Exempla Lutheran Medical Center
- Praxair Cancer Center at Danbury Hospital
- Carl and Dorothy Bennett Cancer Center at Stamford Hospital
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Sibley Memorial Hospital
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
- Halifax Medical Center
- Broward General Medical Center Cancer Center
- University of Florida Shands Cancer Center
- Florida Oncology Associates
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- West Florida Cancer Institute at West Florida Hospital - Pensacola
- John B. Amos Community Cancer Center
- Northeast Georgia Medical Center
- Medical Center of Central Georgia
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- St. Luke's Mountain States Tumor Institute - Boise
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Medical and Surgical Specialists, L L C
- Delnor Community Hospital - Geneva
- Mason District Hospital
- Hinsdale Hematology Oncology Associates
- Hopedale Medical Complex
- Joliet Oncology Hematology Associates, Limited - West
- Kewanee Hospital
- La Grange Memorial Hospital
- McDonough District Hospital
- Good Samaritan Regional Health Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Fort Wayne Medical Oncology and Hematology
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- McFarland Clinic, P. C.
- Hematology Oncology Associates of the Quad Cities
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Heartland Oncology & Hematology
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Ottumwa Regional Health Center Cancer Center
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cedar Valley Medical Specialists, P.C. - West Ridgeway Avenue
- Covenant Cancer Treatment Center
- Cancer Center of Kansas, P.A. - Chanute
- Cancer Center of Kansas, P.A. - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, P.A. - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, P.A. - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Mount Carmel Regional Cancer Center
- Cancer Center of Kansas, P.A. - Pratt
- Cancer Center of Kansas, P.A. - Salina
- Stormont-Vail Cancer Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas, P.A. - Wellington
- Associates in Womens Health, P.A. - North Review
- Cancer Center of Kansas, P.A. - Medical Arts Tower
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, P.A. - Winfield
- Cancer Care at Our Lady of Bellefonte Hospital
- Central Baptist Hospital
- Cancer Treatment Center at Christus Schumpert St. Mary Place
- Central Maine Medical Center
- Mercy Hospital
- Sturdy Memorial Hospital
- Cancer Research Center at Boston Medical Center
- Cancer Center of Boston - Chestnut Hill
- Caritas St. Elizabeth's Medical Center
- Caritas Holy Family Hospital
- Caritas Norwood Hospital
- Hickman Cancer Center at Bixby Medical Center
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
- Spectrum Health Cancer Care - Butterworth Campus
- Metropolitan Hospital
- Holland Community Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Upper Michigan Cancer Center at Marquette General Hospital
- MidMichigan Medical Center - Midland
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- Hackley Hospital
- Northern Michigan Hospital
- St. Joseph Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Munson Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- University of Mississippi Medical Center
- Keesler Medical Center - Keesler Air Force Base
- Saint Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- CCOP - Kansas City
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- St. Anthony's Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- Internal Medicine Associates of Bozeman
- St. James Community Hospital
- Big Sky Oncology
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Health Systems
- Methodist Cancer Center at Methodist Hospital - Omaha
- Seacoast Cancer Center at Wentworth-Douglass Hospital
- Valley Hospital - Ridgewood
- University of New Mexico Cancer Research and Treatment Center
- San Juan Regional Cancer Center
- New York Oncology Hematology, PC - Albany
- Roswell Park Cancer Institute
- Adirondack Cancer Care - Glens Falls
- New York Oncology Hematology, P.C.
- CCOP - North Shore University Hospital
- Long Island Jewish Medical Center
- CCOP - Hematology-Oncology Associates of Central New York
- St. Joseph's Hospital Health Center - Syracuse
- Faxton Regional Cancer Center
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- Presbyterian Cancer Center at Presbyterian Hospital
- John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Pardee Memorial Hospital
- Lenoir Memorial Cancer Center
- Annie Penn Cancer Center
- Rutherford Hospital
- Iredell Memorial Hospital
- Wilson Medical Center
- Forsyth Regional Cancer Center at Forsyth Medical Center
- McDowell Cancer Center at Akron General Medical Center
- Akron City Hospital
- Wood County Oncology Center
- University Hospitals Ireland Cancer Center at Mercy Medical Center
- Adena Regional Medical Center
- Charles M. Barrett Cancer Center at University Hospital
- Huron Hospital Cancer Care Center
- Euclid Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Community Oncology Group at Cleveland Clinic Cancer Center
- Kenton Oncology, Incorporated
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Promedica Cancer Center at Flower Hospital
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical College of Ohio Cancer Institute
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Toledo Surgical Specialists
- UVMC Cancer Care Center at Upper Valley Medical Center
- South Pointe Hospital Cancer Care Center
- Fulton County Health Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Cleveland Clinic - Wooster
- United States Air Force Medical Center Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Tod Children's Hospital - Forum Health
- Genesis - Good Samaritan Hospital
- St. Charles Medical Center - Bend
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Salem Hospital Regional Cancer Center
- Legacy Meridian Park Hospital
- St. Luke's Hospital Cancer Center
- Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center
- Easton Regional Cancer Center at Easton Hospital
- St. Mary Regional Cancer Center
- Allegheny Cancer Center at Allegheny General Hospital
- Reading Hospital and Medical Center
- Jennersville Regional Hospital
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- Roper St. Francis Cancer Center at Roper Hospital
- Hollings Cancer Center at Medical University of South Carolina
- McLeod Regional Medical Center
- Bon Secours St. Francis Health System
- CCOP - Greenville
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Thompson Cancer Survival Center
- Harrington Cancer Center
- Medical City Dallas Hospital
- Presbyterian Hospital of Dallas
- Center for Cancer Medicine and Blood Disorders, PA
- Brooke Army Medical Center
- M.D. Anderson Cancer Center at University of Texas
- Baylor University Medical Center - Houston
- Wilford Hall Medical Center
- UMC Southwest Cancer and Research Center
- American Fork Hospital
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Green Mountain Oncology Group
- Southwestern Vermont Regional Cancer Center
- Martha Jefferson Hospital Cancer Care Center
- Danville Regional Medical Center
- Southwest Virginia Regional Cancer Center
- Auburn Regional Center for Cancer Care
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- Providence Centralia Hospital Regional Cancer Center
- St. Francis Hospital
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Capital Medical Center
- Good Samaritan Cancer Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Rockwood Clinic Cancer Treatment Center
- Providence Cancer Center at Sacred Heart Medical Center
- Providence Cancer Center at Holy Family Hospital
- St. Joseph Medical Center at Franciscan Health System
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Clinic
- United Hospital Center
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Fox Valley Hematology and Oncology - East Grant Street
- Luther Midlelfort Hospital
- Midelfort Clinic - Luther
- Vince Lombardi Cancer Center - Elkhorn
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Medical Consultants, Limited
- All Saints Cancer Center at All Saints Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
- CancerCare Manitoba
- Saint John Regional Hospital
- Nova Scotia Cancer Centre
- Royal Victoria Hospital of Barrie
- Trillium Health Centre - Mississauga Site
- St. Joseph's Health Centre - Toronto
- Allan Blair Cancer Centre at Pasqua Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
gemcitabine hydrochloride + IMC-C225
gemcitabine hydrochloride alone
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.
gemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.