Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
- The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins-bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
- For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
- Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible
- Zubrod performance status 0 or 1
- Complete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
- Complete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelets >= 100,000/mm^3
- Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
- Post resection serum cancer antigen (CA)19-9 =< 180 units/mL AND prior to any systemic treatment
- Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Negative serum pregnancy test for women of childbearing potential within 14 days of study registration
- Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study (or within 31 days prior to day 1 of chemo post-surgery for those patients having started chemotherapy prior to first step registration); patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead
- Signed study-specific informed consent
- Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol
- Women of childbearing potential and male participants must practice adequate contraception
- Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed
Exclusion Criteria:
- Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely IPMN with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible
- Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
- Patients entering on the study after pancreaticoduodenectomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (or first day of chemotherapy for patients having started chemotherapy prior to first step registration); patients with a previous history of carcinoma in situ are eligible
Severe, active co-morbidity, defined as follows per time points indicated below (or per time points indicated below prior to the first day of chemotherapy for patients having started chemotherapy prior to first step registration):
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the 3 months of study registration
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Pregnant or lactating women
- Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible
Sites / Locations
- Providence Hospital
- Alaska Breast Care and Surgery LLC
- Alaska Women's Cancer Care
- Katmai Oncology Group
- Providence Alaska Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Mercy San Juan Medical Center
- East Bay Radiation Oncology Center
- Community Cancer Institute
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Saint Agnes Medical Center
- Marin General Hospital
- UC San Diego Moores Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- El Camino Hospital
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Valley Medical Oncology Consultants
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- Mercy General Hospital Radiation Oncology Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- UC San Diego Medical Center - Hillcrest
- Sharp Memorial Hospital
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Hartford HealthCare - Saint Vincent's Medical Center
- Hartford Hospital
- Midstate Medical Center
- The Hospital of Central Connecticut
- Eastern Connecticut Hematology and Oncology Associates
- William Backus Hospital
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Holy Cross Hospital
- University of Florida Health Science Center - Gainesville
- Mayo Clinic in Florida
- Jupiter Medical Center
- Mount Sinai Medical Center
- Jackson Memorial Hospital-Holtz Children's Hospital
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- AdventHealth Orlando
- Orlando Health Cancer Institute
- Bay Medical Center
- Florida Cancer Affiliates
- Grady Health System
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- John B Amos Cancer Center
- Northeast Georgia Medical Center-Gainesville
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- The Cancer Center of Hawaii-Pali Momi
- Queen's Medical Center
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Joseph Regional Medical Center
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Northwest Community Hospital
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Illinois
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical Center
- Carle at The Riverfront
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Elmhurst Memorial Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Edward Hospital/Cancer Center?Plainfield
- Illinois CancerCare-Princeton
- OSF Saint Anthony Medical Center
- Saint John's Hospital
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Radiation Oncology Associates PC
- Parkview Hospital Randallia
- Goshen Center for Cancer Care
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Methodist Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- Tulane University Health Sciences Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- University of Maryland/Greenebaum Cancer Center
- Sinai Hospital of Baltimore
- Saint Agnes Hospital
- UM Baltimore Washington Medical Center/Tate Cancer Center
- TidalHealth Peninsula Regional
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Boston Medical Center
- Lahey Hospital and Medical Center
- Saint Anne's Hospital
- Berkshire Medical Center - Cancer Center
- Baystate Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Huron Valley-Sinai Hospital
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Green Bay Oncology - Iron Mountain
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Trinity Health Saint Mary Mercy Livonia Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Trinity Health Muskegon Hospital
- Saint Joseph Mercy Oakland
- William Beaumont Hospital-Royal Oak
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- University of Michigan Health - West
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- SSM Health Saint Louis University Hospital
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Cancer Research Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- Renown Regional Medical Center
- Elliot Hospital
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Saint Barnabas Medical Center
- Memorial Sloan Kettering Monmouth
- Virtua Memorial
- Rutgers New Jersey Medical School
- Newark Beth Israel Medical Center
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Sparta Cancer Treatment Center
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- Valley Health System-Hematology/Oncology
- New York Oncology Hematology PC - Albany
- Maimonides Medical Center
- Sands Cancer Center
- Memorial Sloan Kettering Commack
- Glens Falls Hospital
- Memorial Sloan Kettering Westchester
- Garnet Health Medical Center
- NYU Winthrop Hospital
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Memorial Sloan Kettering Cancer Center
- Wilmot Cancer Institute Radiation Oncology at Greece
- Highland Hospital
- University of Rochester
- Memorial Sloan Kettering Sleepy Hollow
- Stony Brook University Medical Center
- Memorial Sloan Kettering Nassau
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Atrium Health Pineville/LCI-Pineville
- Atrium Health Cabarrus/LCI-Concord
- East Carolina University
- AdventHealth Hendersonville
- Vidant Oncology-Kinston
- Matthews Radiation Oncology Center
- UNC Rex Healthcare
- Rutherford Hospital
- Southeast Clinical Oncology Research Consortium NCORP
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Radiation Oncology Center
- Summa Health System - Barberton Campus
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Mercy Cancer Center-Elyria
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Summa Health Medina Medical Center
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- University Hospitals Portage Medical Center
- UH Seidman Cancer Center at Salem Regional Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- Cancer Treatment Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Oregon Health and Science University
- Mid-Columbia Medical Center/Celilo Cancer Center
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Bryn Mawr Hospital
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Delaware County Memorial Hospital
- Northeast Radiation Oncology Center
- Easton Hospital
- Adams Cancer Center
- Cherry Tree Cancer Center
- Riddle Memorial Hospital
- Allegheny Valley Hospital
- Paoli Memorial Hospital
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Jefferson Torresdale Hospital
- Einstein Medical Center Philadelphia
- Guthrie Medical Group PC-Robert Packer Hospital
- Crozer-Chester Medical Center
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Hospital
- Rhode Island Hospital
- Radiation Oncology Associates Incorporated
- Miriam Hospital
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Carolina Blood and Cancer Care Associates PA
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Vanderbilt University/Ingram Cancer Center
- The Don and Sybil Harrington Cancer Center
- Texas Oncology-Arlington South
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology Bedford
- Texas Oncology - Denison Cancer Center
- Texas Oncology-Flower Mound
- Texas Oncology - Fort Worth Cancer Center
- University of Texas Medical Branch
- Memorial Hermann Memorial City Medical Center
- M D Anderson Cancer Center
- UTMB Cancer Center at Victory Lakes
- Texas Oncology - Lewisville
- Texas Oncology-Longview Cancer Center
- Texas Oncology-McKinney
- Texas Oncology-Seton Williamson
- Texas Oncology - Round Rock Cancer Center
- Cancer Care Centers of South Texas- Northeast
- Texas Oncology Cancer Center Sugar Land
- Scott and White Memorial Hospital
- Tyler Cancer Center
- Deke Slayton Cancer Center
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Fredericksburg Oncology Inc
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Sentara Norfolk General Hospital
- Sentara Virginia Beach General Hospital
- MultiCare Auburn Medical Center
- Overlake Medical Center
- Providence Regional Cancer System-Centralia
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Providence - Saint Peter Hospital
- Capital Medical Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Cancer Care Northwest - Spokane South
- Cancer Care Northwest-North Spokane
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Legacy Salmon Creek Hospital
- West Virginia University Charleston Division
- West Virginia University Healthcare
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer Center
- Marshfield Clinic-Chippewa Center
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Green Bay Oncology at Saint Vincent Hospital
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Ascension Saint Mary's Hospital
- Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Ascension Saint Michael's Hospital
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Green Bay Oncology - Sturgeon Bay
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- Hospital Univ. Erasme
- University Hospital Saint Luc
- Algemeen Ziekenhuis Groeninge Campus Kennedylaan
- AZ Turnhout-Campus Saint Elizabeth
- London Regional Cancer Program
- Ottawa Hospital and Cancer Center-General Campus
- Ottawa Hospital-Civic Campus
- CHUM - Hopital Notre-Dame
- CHUM - Centre Hospitalier de l'Universite de Montreal
- Rabin Medical Center
- Tel Aviv Sourasky Medical Center
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Arm I (gemcitabine hydrochloride or combination chemotherapy)
Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
Arm III (chemotherapy)
Arm IV (chemotherapy, chemoradiotherapy)
Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline. (closed to accrual 4/2/14)
Patients receive the same treatment as in arm I for 1 month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.