A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

Who is this study for? Adult patients with pancreatic cancer
Status: Active, not recruiting
Location: See all (698) locations...
Intervention Type: Other, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This randomized phase II-R/III trial studies 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 was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Alabama
Providence Hospital
Mobile
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Mills-Peninsula Medical Center
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Mercy San Juan Medical Center
Carmichael
East Bay Radiation Oncology Center
Castro Valley
Community Cancer Institute
Clovis
City of Hope Comprehensive Cancer Center
Duarte
Epic Care-Dublin
Dublin
Bay Area Breast Surgeons Inc
Emeryville
Epic Care Partners in Cancer Care
Emeryville
Kaiser Permanente-Fremont
Fremont
Fresno Cancer Center
Fresno
Saint Agnes Medical Center
Fresno
Marin General Hospital
Greenbrae
UC San Diego Moores Cancer Center
La Jolla
Cedars Sinai Medical Center
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Contra Costa Regional Medical Center
Martinez
Kaiser Permanente-Modesto
Modesto
Memorial Medical Center
Modesto
El Camino Hospital
Mountain View
Alta Bates Summit Medical Center - Summit Campus
Oakland
Bay Area Tumor Institute
Oakland
Hematology and Oncology Associates-Oakland
Oakland
Highland General Hospital
Oakland
Kaiser Permanente Oakland-Broadway
Oakland
Kaiser Permanente-Oakland
Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Palo Alto Medical Foundation Health Care
Palo Alto
Valley Medical Oncology Consultants
Pleasanton
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova
Kaiser Permanente-Redwood City
Redwood City
Kaiser Permanente-Richmond
Richmond
Rohnert Park Cancer Center
Rohnert Park
Kaiser Permanente-Roseville
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
Kaiser Permanente - Sacramento
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
Mercy General Hospital Radiation Oncology Center
Sacramento
South Sacramento Cancer Center
Sacramento
Sutter Medical Center Sacramento
Sacramento
Saint Helena Hospital
Saint Helena
Sharp Memorial Hospital
San Diego
UC San Diego Medical Center - Hillcrest
San Diego
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Francisco
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo
Kaiser Permanente-San Rafael
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Kaiser Permanente-Santa Rosa
Santa Rosa
Kaiser Permanente Cancer Treatment Center
South San Francisco
Kaiser Permanente-South San Francisco
South San Francisco
Kaiser Permanente-Stockton
Stockton
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Sutter Solano Medical Center/Cancer Center
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
The Medical Center of Aurora
Aurora
University of Colorado Hospital
Aurora
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
UCHealth Memorial Hospital Central
Colorado Springs
Colorado Blood Cancer Institute
Denver
Porter Adventist Hospital
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Rose Medical Center
Denver
SCL Health Saint Joseph Hospital
Denver
Western States Cancer Research NCORP
Denver
Mercy Medical Center
Durango
Mountain Blue Cancer Care Center - Swedish
Englewood
Swedish Medical Center
Englewood
Poudre Valley Hospital
Fort Collins
Mountain Blue Cancer Care Center
Golden
Saint Mary's Hospital and Regional Medical Center
Grand Junction
North Colorado Medical Center
Greeley
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Sky Ridge Medical Center
Lone Tree
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
McKee Medical Center
Loveland
Parker Adventist Hospital
Parker
Rocky Mountain Cancer Centers-Parker
Parker
Rocky Mountain Cancer Centers - Pueblo
Pueblo
Saint Mary Corwin Medical Center
Pueblo
North Suburban Medical Center
Thornton
Rocky Mountain Cancer Centers-Thornton
Thornton
SCL Health Lutheran Medical Center
Wheat Ridge
Connecticut
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport
Hartford Hospital
Hartford
Midstate Medical Center
Meriden
The Hospital of Central Connecticut
New Britain
Eastern Connecticut Hematology and Oncology Associates
Norwich
William Backus Hospital
Norwich
Washington, D.c.
MedStar Georgetown University Hospital
Washington
MedStar Washington Hospital Center
Washington
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Christiana Gynecologic Oncology LLC
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
Holy Cross Hospital
Fort Lauderdale
University of Florida Health Science Center - Gainesville
Gainesville
Mayo Clinic in Florida
Jacksonville
Jupiter Medical Center
Jupiter
Jackson Memorial Hospital-Holtz Children's Hospital
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Mount Sinai Medical Center
Miami Beach
AdventHealth Orlando
Orlando
Orlando Health Cancer Institute
Orlando
Bay Medical Center
Panama City
Florida Cancer Affiliates
Trinity
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Grady Health System
Atlanta
John B Amos Cancer Center
Columbus
Northeast Georgia Medical Center-Gainesville
Gainesville
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Memorial Health University Medical Center
Savannah
Hawaii
The Cancer Center of Hawaii-Pali Momi
'aiea
Hawaii Cancer Care Inc-Liliha
Honolulu
Kaiser Permanente Moanalua Medical Center
Honolulu
Queen's Medical Center
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic PC - Ames
Ames
McFarland Clinic PC-Boone
Boone
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
Iowa-Wide Oncology Research Coalition NCORP
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Des Moines
Mercy Medical Center - Des Moines
Des Moines
Mission Cancer and Blood - Laurel
Des Moines
McFarland Clinic PC-Jefferson
Jefferson
McFarland Clinic PC-Marshalltown
Marshalltown
Mercy Medical Center-Sioux City
Sioux City
Saint Luke's Regional Medical Center
Sioux City
Siouxland Regional Cancer Center
Sioux City
Mercy Medical Center-West Lakes
West Des Moines
Methodist West Hospital
West Des Moines
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Joseph Regional Medical Center
Lewiston
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Saint Anthony's Health
Alton
Northwest Community Hospital
Arlington Heights
Rush - Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
Saint Joseph Medical Center
Bloomington
Illinois CancerCare-Canton
Canton
Illinois CancerCare-Carthage
Carthage
Advocate Illinois Masonic Medical Center
Chicago
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Presence Resurrection Medical Center
Chicago
Rush University Medical Center
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Carle on Vermilion
Danville
Decatur Memorial Hospital
Decatur
Carle Physician Group-Effingham
Effingham
Elmhurst Memorial Hospital
Elmhurst
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
Ingalls Memorial Hospital
Harvey
Presence Saint Mary's Hospital
Kankakee
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Loyola University Medical Center
Maywood
Good Samaritan Regional Health Center
Mount Vernon
Edward Hospital/Cancer Center
Naperville
Carle Cancer Institute Normal
Normal
Illinois CancerCare-Ottawa Clinic
Ottawa
Radiation Oncology of Northern Illinois
Ottawa
Illinois CancerCare-Pekin
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Edward Hospital/Cancer Center?Plainfield
Plainfield
Illinois CancerCare-Princeton
Princeton
OSF Saint Anthony Medical Center
Rockford
Memorial Medical Center
Springfield
Saint John's Hospital
Springfield
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Rush-Copley Healthcare Center
Yorkville
Indiana
Franciscan Saint Francis Health-Beech Grove
Beech Grove
Elkhart Clinic
Elkhart
Elkhart General Hospital
Elkhart
Michiana Hematology Oncology PC-Elkhart
Elkhart
Parkview Hospital Randallia
Fort Wayne
Radiation Oncology Associates PC
Fort Wayne
Goshen Center for Cancer Care
Goshen
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
IU Health Methodist Hospital
Indianapolis
Community Howard Regional Health
Kokomo
IU Health La Porte Hospital
La Porte
Woodland Cancer Care Center
Michigan City
Memorial Regional Cancer Center Day Road
Mishawaka
Michiana Hematology Oncology PC-Mishawaka
Mishawaka
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka
Michiana Hematology Oncology PC-Plymouth
Plymouth
Reid Health
Richmond
Memorial Hospital of South Bend
South Bend
Michiana Hematology Oncology PC-South Bend
South Bend
Northern Indiana Cancer Research Consortium
South Bend
Michiana Hematology Oncology PC-Westville
Westville
Kansas
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas-Manhattan
Manhattan
Cancer Center of Kansas - McPherson
Mcpherson
Cancer Center of Kansas - Newton
Newton
Menorah Medical Center
Overland Park
Saint Luke's South Hospital
Overland Park
Cancer Center of Kansas - Parsons
Parsons
Kansas City NCI Community Oncology Research Program
Prairie Village
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka
Cancer Center of Kansas - Wellington
Wellington
Ascension Via Christi Hospitals Wichita
Wichita
Associates In Womens Health
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Wesley Medical Center
Wichita
Wichita NCI Community Oncology Research Program
Wichita
Cancer Center of Kansas - Winfield
Winfield
Kentucky
Baptist Health Lexington
Lexington
University of Kentucky/Markey Cancer Center
Lexington
Louisiana
Ochsner Medical Center Jefferson
New Orleans
Tulane University Health Sciences Center
New Orleans
LSU Health Sciences Center at Shreveport
Shreveport
Massachusetts
Boston Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital Cancer Center
Boston
Lahey Hospital and Medical Center
Burlington
Saint Anne's Hospital
Fall River
Berkshire Medical Center - Cancer Center
Pittsfield
Baystate Medical Center
Springfield
Maryland
Saint Agnes Hospital
Baltimore
Sinai Hospital of Baltimore
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie
TidalHealth Peninsula Regional
Salisbury
Michigan
Bixby Medical Center
Adrian
Hickman Cancer Center
Adrian
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Huron Valley-Sinai Hospital
Commerce
Ascension Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Green Bay Oncology - Escanaba
Escanaba
Weisberg Cancer Treatment Center
Farmington Hills
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
Green Bay Oncology - Iron Mountain
Iron Mountain
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Mercy Memorial Hospital
Monroe
Toledo Clinic Cancer Centers-Monroe
Monroe
Mercy Health Mercy Campus
Muskegon
Saint Joseph Mercy Oakland
Pontiac
William Beaumont Hospital-Royal Oak
Royal Oak
Lakeland Medical Center Saint Joseph
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
William Beaumont Hospital - Troy
Troy
Saint John Macomb-Oakland Hospital
Warren
Henry Ford West Bloomfield Hospital
West Bloomfield
Metro Health Hospital
Wyoming
Minnesota
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Unity Hospital
Fridley
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Hennepin County Medical Center
Minneapolis
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic in Rochester
Rochester
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Missouri
Central Care Cancer Center - Bolivar
Bolivar
Parkland Health Center-Bonne Terre
Bonne Terre
Cox Cancer Center Branson
Branson
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
University of Missouri - Ellis Fischel
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Centerpoint Medical Center LLC
Independence
Capital Region Southwest Campus
Jefferson City
Freeman Health System
Joplin
Mercy Hospital Joplin
Joplin
Heartland Hematology and Oncology Associates Incorporated
Kansas City
Research Medical Center
Kansas City
Saint Luke's Hospital of Kansas City
Kansas City
Saint Luke's East - Lee's Summit
Lee's Summit
Liberty Radiation Oncology Center
Liberty
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Heartland Regional Medical Center
Saint Joseph
Center for Cancer Care and Research
Saint Louis
Mercy Hospital Saint Louis
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Saint Louis-Cape Girardeau CCOP
Saint Louis
Siteman Cancer Center-South County
Saint Louis
SSM Health Saint Louis University Hospital
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
Cancer Research for the Ozarks NCORP
Springfield
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mississippi
University of Mississippi Medical Center
Jackson
Singing River Hospital
Pascagoula
Montana
Billings Clinic Cancer Center
Billings
Montana Cancer Consortium NCORP
Billings
Northern Rockies Radiation Oncology Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Berdeaux, Donald MD (UIA Investigator)
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Kalispell Regional Medical Center
Kalispell
Montana Cancer Specialists
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
Atrium Health Pineville/LCI-Pineville
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Charlotte
Novant Health Presbyterian Medical Center
Charlotte
Atrium Health Cabarrus/LCI-Concord
Concord
East Carolina University
Greenville
AdventHealth Hendersonville
Hendersonville
Vidant Oncology-Kinston
Kinston
Matthews Radiation Oncology Center
Matthews
UNC Rex Healthcare
Raleigh
Rutherford Hospital
Rutherfordton
Southeast Clinical Oncology Research Consortium NCORP
Winston-salem
Nebraska
CHI Health Saint Francis
Grand Island
CHI Health Good Samaritan
Kearney
Nebraska Cancer Research Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Missouri Valley Cancer Consortium
Omaha
Nebraska Methodist Hospital
Omaha
University of Nebraska Medical Center
Omaha
New Hampshire
Elliot Hospital
Manchester
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Cooper Hospital University Medical Center
Camden
Saint Barnabas Medical Center
Livingston
Memorial Sloan Kettering Monmouth
Middletown
Virtua Memorial
Mount Holly
Newark Beth Israel Medical Center
Newark
Rutgers New Jersey Medical School
Newark
The Valley Hospital-Luckow Pavilion
Paramus
Valley Hospital
Ridgewood
Sparta Cancer Treatment Center
Sparta
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees
Virtua Voorhees
Voorhees
Valley Health System-Hematology/Oncology
Westwood
Nevada
Cancer and Blood Specialists-Henderson
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson
GenesisCare USA - Henderson
Henderson
Las Vegas Cancer Center-Henderson
Henderson
Cancer and Blood Specialists-Shadow
Las Vegas
Cancer and Blood Specialists-Tenaya
Las Vegas
Cancer Therapy and Integrative Medicine
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
GenesisCare USA - Fort Apache
Las Vegas
GenesisCare USA - Las Vegas
Las Vegas
GenesisCare USA - Vegas Tenaya
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas
Las Vegas Cancer Center-Medical Center
Las Vegas
Nevada Cancer Research Foundation NCORP
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
Renown Regional Medical Center
Reno
New York
New York Oncology Hematology PC - Albany
Albany
Maimonides Medical Center
Brooklyn
Sands Cancer Center
Canandaigua
Memorial Sloan Kettering Commack
Commack
Glens Falls Hospital
Glens Falls
Memorial Sloan Kettering Westchester
Harrison
Garnet Health Medical Center
Middletown
NYU Winthrop Hospital
Mineola
Long Island Jewish Medical Center
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Memorial Sloan Kettering Cancer Center
New York
Highland Hospital
Rochester
University of Rochester
Rochester
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow
Stony Brook University Medical Center
Stony Brook
Memorial Sloan Kettering Nassau
Uniondale
Ohio
Cleveland Clinic Akron General
Akron
Summa Health System - Akron Campus
Akron
Radiation Oncology Center
Alliance
Summa Health System - Barberton Campus
Barberton
Strecker Cancer Center-Belpre
Belpre
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green
Adena Regional Medical Center
Chillicothe
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
MetroHealth Medical Center
Cleveland
Columbus NCI Community Oncology Research Program
Columbus
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel Health Center West
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Good Samaritan Hospital - Dayton
Dayton
Grandview Hospital
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Delaware Radiation Oncology
Delaware
Grady Memorial Hospital
Delaware
Mercy Cancer Center-Elyria
Elyria
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Cleveland Clinic Cancer Center Independence
Independence
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
Lancaster Radiation Oncology
Lancaster
Lima Memorial Hospital
Lima
Marietta Memorial Hospital
Marietta
Toledo Clinic Cancer Centers-Maumee
Maumee
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee
Hillcrest Hospital Cancer Center
Mayfield Heights
Summa Health Medina Medical Center
Medina
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Saint Charles Hospital
Oregon
Toledo Clinic Cancer Centers-Oregon
Oregon
Southern Ohio Medical Center
Portsmouth
University Hospitals Portage Medical Center
Ravenna
UH Seidman Cancer Center at Salem Regional Medical Center
Salem
North Coast Cancer Care
Sandusky
Springfield Regional Medical Center
Springfield
Cleveland Clinic Cancer Center Strongsville
Strongsville
ProMedica Flower Hospital
Sylvania
Mercy Hospital of Tiffin
Tiffin
Mercy Health - Saint Anne Hospital
Toledo
Saint Vincent Mercy Medical Center
Toledo
Toledo Clinic Cancer Centers-Toledo
Toledo
Toledo Community Hospital Oncology Program CCOP
Toledo
University of Toledo
Toledo
Upper Valley Medical Center
Troy
Fulton County Health Center
Wauseon
University of Cincinnati Cancer Center-West Chester
West Chester
Saint Ann's Hospital
Westerville
Cancer Treatment Center
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster
Greene Memorial Hospital
Xenia
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa
Oregon
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Legacy Mount Hood Medical Center
Gresham
Providence Milwaukie Hospital
Milwaukie
Providence Newberg Medical Center
Newberg
Providence Willamette Falls Medical Center
Oregon City
Legacy Good Samaritan Hospital and Medical Center
Portland
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Mid-Columbia Medical Center/Celilo Cancer Center
The Dalles
Pennsylvania
Jefferson Abington Hospital
Abington
Lehigh Valley Hospital-Cedar Crest
Allentown
Bryn Mawr Hospital
Bryn Mawr
Geisinger Medical Center
Danville
Mercy Fitzgerald Hospital
Darby
Delaware County Memorial Hospital
Drexel Hill
Northeast Radiation Oncology Center
Dunmore
Easton Hospital
Easton
Adams Cancer Center
Gettysburg
Cherry Tree Cancer Center
Hanover
Riddle Memorial Hospital
Media
Allegheny Valley Hospital
Natrona Heights
Paoli Memorial Hospital
Paoli
Einstein Medical Center Philadelphia
Philadelphia
Jefferson Torresdale Hospital
Philadelphia
Pennsylvania Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Guthrie Medical Group PC-Robert Packer Hospital
Sayre
Crozer-Chester Medical Center
Upland
Reading Hospital
West Reading
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
Lankenau Medical Center
Wynnewood
Main Line Health NCORP
Wynnewood
WellSpan Health-York Hospital
York
Rhode Island
Miriam Hospital
Providence
Radiation Oncology Associates Incorporated
Providence
Rhode Island Hospital
Providence
South Carolina
AnMed Health Cancer Center
Anderson
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Easley
Easley
Greenville Health System Cancer Institute-Andrews
Greenville
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
Prisma Health Cancer Institute - Greer
Greer
Carolina Blood and Cancer Care Associates PA-Lancaster
Lancaster
Carolina Blood and Cancer Care Associates PA
Rock Hill
Prisma Health Cancer Institute - Seneca
Seneca
Spartanburg Medical Center
Spartanburg
South Dakota
Rapid City Regional Hospital
Rapid City
Avera Cancer Institute
Sioux Falls
Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
The Don and Sybil Harrington Cancer Center
Amarillo
Texas Oncology-Arlington South
Arlington
Texas Oncology - Central Austin Cancer Center
Austin
Texas Oncology - South Austin Cancer Center
Austin
Texas Oncology-Austin Midtown
Austin
Texas Oncology Bedford
Bedford
Texas Oncology - Denison Cancer Center
Denison
Texas Oncology-Flower Mound
Flower Mound
Texas Oncology - Fort Worth Cancer Center
Fort Worth
University of Texas Medical Branch
Galveston
M D Anderson Cancer Center
Houston
Memorial Hermann Memorial City Medical Center
Houston
UTMB Cancer Center at Victory Lakes
League City
Texas Oncology - Lewisville
Lewisville
Texas Oncology-Longview Cancer Center
Longview
Texas Oncology-McKinney
Mckinney
Texas Oncology - Round Rock Cancer Center
Round Rock
Texas Oncology-Seton Williamson
Round Rock
Cancer Care Centers of South Texas- Northeast
San Antonio
Texas Oncology Cancer Center Sugar Land
Sugar Land
Scott and White Memorial Hospital
Temple
Tyler Cancer Center
Tyler
Deke Slayton Cancer Center
Webster
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork
Sandra L Maxwell Cancer Center
Cedar City
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center
Provo
Saint George Regional Medical Center
Saint George
Huntsman Cancer Institute/University of Utah
Salt Lake City
LDS Hospital
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
Fredericksburg Oncology Inc
Fredericksburg
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton
Sentara Norfolk General Hospital
Norfolk
Sentara Virginia Beach General Hospital
Virginia Beach
Washington
MultiCare Auburn Medical Center
Auburn
Overlake Medical Center
Bellevue
Providence Regional Cancer System-Centralia
Centralia
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Capital Medical Center
Olympia
Providence - Saint Peter Hospital
Olympia
MultiCare Good Samaritan Hospital
Puyallup
Tacoma/Valley Radiation Oncology Centers-Puyallup
Puyallup
Cancer Care Northwest - Spokane South
Spokane
Cancer Care Northwest-North Spokane
Spokane
MultiCare Allenmore Hospital
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Northwest NCI Community Oncology Research Program
Tacoma
Saint Joseph Medical Center
Tacoma
Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma
Compass Oncology Vancouver
Vancouver
Legacy Salmon Creek Hospital
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Wisconsin
Langlade Hospital and Cancer Center
Antigo
Marshfield Clinic-Chippewa Center
Chippewa Falls
HSHS Sacred Heart Hospital
Eau Claire
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire
Bellin Memorial Hospital
Green Bay
Green Bay Oncology at Saint Vincent Hospital
Green Bay
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Gundersen Lutheran Medical Center
La Crosse
Bay Area Medical Center
Marinette
Marshfield Medical Center
Marshfield
Marshfield Medical Center-Marshfield
Marshfield
Medical College of Wisconsin
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
Cancer Center of Western Wisconsin
New Richmond
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls
Ascension Saint Mary's Hospital
Rhinelander
Saint Mary's Hospital
Rhinelander
Marshfield Medical Center-Rice Lake
Rice Lake
Ascension Saint Michael's Hospital
Stevens Point
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aspirus Regional Cancer Center
Wausau
Marshfield Clinic-Wausau Center
Wausau
Diagnostic and Treatment Center
Weston
Marshfield Medical Center - Weston
Weston
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids
West Virginia
West Virginia University Charleston Division
Charleston
West Virginia University Healthcare
Morgantown
Wheeling Hospital/Schiffler Cancer Center
Wheeling
Wyoming
Rocky Mountain Oncology
Casper
Welch Cancer Center
Sheridan
Other Locations
Belgium
Hospital Univ. Erasme
Brussels
University Hospital Saint Luc
Brussels
Algemeen Ziekenhuis Groeninge Campus Kennedylaan
Kortrijk
AZ Turnhout-Campus Saint Elizabeth
Turnhout
Canada
London Regional Cancer Program
London
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal
CHUM - Hopital Notre-Dame
Montreal
Ottawa Hospital and Cancer Center-General Campus
Ottawa
Ottawa Hospital-Civic Campus
Ottawa
Israel
Rabin Medical Center
Petach Tikva
Tel Aviv Sourasky Medical Center
Tel Aviv
Chaim Sheba Medical Center
Tel Hashomer
Time Frame
Start Date: November 17, 2009
Estimated Completion Date: December 31, 2022
Participants
Target number of participants: 545
Treatments
Active Comparator: Arm I (gemcitabine hydrochloride or combination chemotherapy)
Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months.
Experimental: Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 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. (closed to accrual 4/2/14)
Experimental: Arm III (chemotherapy)
Patients receive the same treatment as in arm I for 1 month.
Experimental: Arm IV (chemotherapy, chemoradiotherapy)
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.
Authors
Laura M. Nadeau, Benjamin B. Bridges, William R. Robinson, Desiree E. Doncals, John A. Pablo, David T. Marshall, Shane Lloyd, Michael G. Haddock, Delia Radovich, Thomas J. Gergel, Lloyd T. Miyawaki, Pamela A. Lepera, Robert J. Behrens, Hassan I. Tahsildar, Minh T. Truong, Adam C. Berger, Paul G. Montgomery, Paul N. Page, Laurent Brard, Scott S. Williams, Albert Yuen, Bryan A. Faller, Howard Safran, Eva N. Christensen, Charles S. Cathcart, Philip A. Lowry, Patricia C. Griffin, Rex B. Mowat, Paul W. Sperduto, Louis Fehrenbacher, Yuhchyau Chen, Bruce J. Averbook, Andrew Y. Kee, Michael C. Hardacre, Jay W. Carlson, Steven J. Jubelirer, Amy K. Krie, Mehmet S. Copur, Kalika P. Sarma, Loren K. Mell, David A. Hornback, Wayne H. Pinover, Aaron W. Pederson, Thomas E. Lad, Syma Iqbal, Robin T. Zon, Timothy D. Moore, Christine Van Cott, Christopher U. Jones, Michael L. Haas, Jeffrey H. Muler, Bradley W. Lash, Stephen S. Nigh, Karyn A. Goodman, Albert S. DeNittis, Michael M. Dominello, Lorraine Portelance, John P. Stoutenburg, Keren Sturtz, Abhijit B. Saste, Uma G. Swamy, Brian K. Chang, Daniel J. Buchholz, Tara E. Seery, Alexander M. Stessin, Roland B. Hawkins, David J. Tate, Ashish B. Patel, Samuel P. Au, Richard S. Hudes, Eleanor M. Walker, Kurt Oettel, Mahesh R. Kudrimoti, R. J. Lee, Mitchel L. Fromm, Jason A. Zell, Adam Raben, William R. Silveira, Andrew D. Vassil, Alexander Hantel, Malcolm D. Mattes, Ross A Abrams, Frank G. Lake, Samir Narayan, Neal B. Goldberg, Donald B. Wender, David L. Grisell, Andrew W. Pippas, Michael J. Swartz, Robert M. Barone, Rachelle M. Lanciano, Peter R. Watson, Barbara J. Fisher, Lemuel S. Ariaratnam, Shaker R. Dakhil, Bernadine Donahue, Abraham J. Wu, John P. Hayes, Seth A. Kaufman, Peter A. Paximadis, Samantha A. Seaward, Chi Lin, Thomas J. Rakowski, Neeta K. Venepalli, John E. Doster, Nasfat Shehadeh, James A. Wheeler, Firas B. Badin, Charlie C. Pan, Michael R. Girvigian, Rajen P. Oza, Jondavid Pollock, Keith E. Stuart, Parag J. Parikh, James L. Wade, Benjamin T. Marchello, Terence S. Herman, William F. Regine, Sulochana D. Yalavarthi, Clinton H. Leinweber, Brian Knab, Kevin L. Du, Raymond L. Dugal, Ashiq Masood, Vivek S. Kavadi, Mayer Gorbaty, Justin J. Wu, Nima Nabavizadeh, Thomas J. George, Christopher M. George, J. S. Thompson, Richard Y. Lee, Rakesh Gaur, Anuradha B. Chakravarthy, Krishna Reddy, Ravit Geva, William Small, Tien-Shew W. Huang, Susannah (Yovino) Ellsworth, Jason R. Pantarotto, Marie-Pierre Campeau, Kathleen J. Yost, John A. Ellerton, James H. Feusner, Dayssy A. Diaz Pardo, John A. Keech, Bassel F. El-Rayes
Sponsors
Collaborators: NRG Oncology
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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