S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring recurrent esophageal cancer, stage IV esophageal cancer, recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the gastroesophageal junction, stage IIIB gastric cancer, stage IIIC gastric cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, adenocarcinoma of the esophagus, adenocarcinoma of the stomach
Eligibility Criteria
DISEASE CHARACTERISTICS:
Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
- Patients must not have received treatment for metastatic or unresectable disease
- Patients must not have brain metastases
- Patients must have measurable and/or non-measurable disease
- Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
- Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration
PATIENT CHARACTERISTICS:
- Zubrod performance status of 0-1
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
- AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN
- Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance > 60 mL/min
- Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0
- Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- All palliative radiation therapy alone must be completed at least 14 days prior to registration
- Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment
Sites / Locations
- University of South Alabama Mitchell Cancer Institute
- University of Arkansas for Medical Sciences
- Sutter Auburn Faith Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Mills - Peninsula Hospitals
- Sutter Davis Hospital
- Los Angeles County-USC Medical Center
- University of Southern California/Norris Cancer Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- University of California Medical Center At Irvine-Orange Campus
- Palo Alto Medical Foundation Health Care
- Valley Medical Oncology Consultants
- Sutter Roseville Medical Center
- Sutter General Hospital
- University of California at Davis Cancer Center
- California Pacific Medical Center-Pacific Campus
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Atlo Medical Foundation-Sunnyvale
- Tahoe Forest Cancer Center
- Sutter Solano Medical Center/Cancer Center
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Colorado Blood Cancer Institute
- Mercy Medical Center
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Breast Cancer Care Consultants
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- 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
- Exempla Lutheran Medical Center
- Saint Francis Hospital and Medical Center
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Holy Cross Hospital
- Broward Health Medical Center
- Memorial Healthcare System - Joe DiMaggio Children's Hospital
- Jupiter Medical Center
- Mount Sinai Medical Center
- Florida Hospital
- Memorial Hospital West
- Phoebe Putney Memorial Hospital
- John B Amos Cancer Center
- Memorial University Medical Center
- Oncare Hawaii Inc-Pali Momi
- Pali Momi Medical Center
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- OnCare Hawaii-Liliha
- Kuakini Medical Center
- Oncare Hawaii Inc-Kuakini
- Kapiolani Medical Center for Women and Children
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute-Meredian
- Kootenai Cancer Center
- Saint Anthony's Health
- Illinois CancerCare-Bloomington
- Saint Joseph Medical Center
- Graham Hospital Association
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Memorial Hospital
- Centralia Oncology Clinic
- Hematology and Oncology Associates
- Northwestern University
- University of Illinois
- Cancer Care Center of Decatur
- Central Illinois CCOP
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Eureka Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare Galesburg
- Illinois CancerCare-Galesburg Cottage Plaza Office
- Illinois CancerCare-Havana
- Mason District Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Adventist La Grange Memorial Hospital
- North Shore Hematology Oncology
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Hematology Oncology Consultants Limited
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- Pekin Cancer Treatment Center
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Illinois CancerCare-Spring Valley
- Memorial Medical Center
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Franciscan Saint Francis Health-Indianapolis
- Community Howard Regional Health
- IU Health La Porte Hospital
- Premier Oncology Hematology Associates
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Cancer Care Partners LLC
- Michiana Hematology Oncology PC-Plymouth
- Reid Hospital and Health Care Services
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology-PC Westville
- Mary Greeley Medical Center
- McFarland Clinic PC-William R Bliss Cancer Center
- Constantinou, Costas L MD (UIA Investigator)
- Hematology Oncology Associates-Quad Cities
- McFarland Clinic PC-Boone
- Genesis Medical Center - East Campus
- McFarland Clinic PC-Trinity Cancer Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Covenant Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- Hays Medical Center
- Promise Regional Medical Center-Hutchinson
- Cancer Center of Kansas-Independence
- Kansas City Cancer Center-West
- Providence Medical Center
- University of Kansas Medical Center
- 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
- Kansas City Cancer Centers-Southwest
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Kansas City CCOP
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Kansas City Cancer Center-Shawnee Mission
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Inc-Crestview
- Ochsner Health Center-Summa
- Ochsner Baptist Medical Center
- Ochsner Medical Center Jefferson
- Louisiana State University Health Sciences Center Shreveport
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Greater Baltimore Medical Center
- Union Hospital of Cecil County
- Frederick Memorial Hospital
- Bixby Medical Center
- Hickman Cancer Center
- Veteran's Administration Medical Center - Ann Arbor
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- University of Michigan University Hospital
- University of Michigan
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Oakwood Hospital and Medical Center
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Genesys Regional Medical Center
- Grand Rapids Clinical Oncology Program
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Mercy Health Mercy Campus
- Lakeland Community Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Spectrum Health Reed City Hospital
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Sanford Clinic North-Bemidgi
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center-Carrie J Babb Cancer Center
- Saint Francis Medical Center
- Southeast Cancer Center
- Centerpoint Medical Center LLC
- Capital Region Medical Center-Goldschmidt Cancer Center
- Freeman Health System
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Kansas City Cancer Center - South
- Research Medical Center
- Kansas City Cancer Centers - North
- Kansas City Cancer Center-Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Hospital
- Phelps County Regional Medical Center
- Saint John's Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Missouri Baptist Medical Center
- Comprehensive Cancer Care PC
- Saint John's Mercy Medical Center
- Mercy Hospital Springfield
- Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
- CoxHealth South Hospital
- Montana Cancer Consortium CCOP
- Saint Vincent Healthcare
- Billings Clinic
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Big Sky Oncology
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Good Samaritan Hospital
- New Hampshire Oncology-Hematology PA
- New Hampshire Oncology Hematology Associates
- LRGHealthcare-Lakes Region General Hospital
- Cooper Hospital University Medical Center
- Monmouth Medical Center
- UMDNJ - New Jersey Medical School
- Inspira Medical Center Vineland
- University of New Mexico
- Arnot Ogden Medical Center
- Glens Falls Hospital
- New York University Langone Medical Center
- University of Rochester
- Randolph Hospital
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Park Ridge Hospital Breast Health Center
- Southeastern Medical Oncology Center-Jacksonville
- Kinston Medical Specialists PA
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Annie Penn Memorial Hospital
- Rutherford Hospital
- Iredell Memorial Hospital
- Southeastern Medical Oncology Center-Wilson
- Southeast Cancer Control Consortium CCOP
- Roger Maris Cancer Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Altru Cancer Center
- Summa Akron City Hospital/Cooper Cancer Center
- Akron General Medical Center
- Summa Barberton Hospital
- Toledo Clinic Cancer Centers-Bowling Green
- Oncology Hematology Care Inc-Mercy West
- Oncology and Hematology Care Inc-Taft
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc - Kenwood
- Oncology Hematology Care Inc-Blue Ash
- University of Cincinnati
- MetroHealth Medical Center
- Ohio State University Medical Center
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton CCOP
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Saint Rita's Medical Center
- Lima Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- University of Oklahoma Health Sciences Center
- Oklahoma Oncology Inc
- Natalie Warren Bryant Cancer Center at Saint Francis
- Warren Cancer Research Foundation
- Tulsa Cancer Institute
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Western Oncology Research Consortium
- Providence Saint Vincent Medical Center
- Lehigh Valley Hospital
- Lehigh Valley Hospital - Muhlenberg
- Lancaster General Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- University of Pittsburgh
- AnMed Health Cancer Center
- AnMed Health Hospital
- Roper Hospital
- Charleston Hematology Oncology Associates-Roper
- Lowcountry Hematology Oncology PA-Charleston
- Charleston Hematology Oncology Associates PA-St. Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Greenville Health System Cancer Institute-Easley
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute/Eastside
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
- Greenville Health System Cancer Institute-Spartanburg
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Baylor College of Medicine
- Ben Taub General Hospital
- Veterans Administration Medical Center
- Fredericksburg Oncology Inc
- Virginia Commonwealth University
- Cancer Care Center at Island Hospital
- Auburn Regional Medical Center
- Overlake Hospital Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Columbia Basin Hematology and Oncology PLLC
- Cascade Cancer Center
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- Saint John Medical Center
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Good Samaritan Community Hospital
- Harborview Medical Center
- Minor and James Medical PLLC
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- Allenmore Hospital
- Northwest CCOP
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Multicare Health System
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Wenatchee Valley Medical Center
- Langlade Hospital and Cancer Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Sacred Heart Hospital
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Gundersen Lutheran
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Marshfield Clinic
- Saint Joseph's Hospital
- Marshfield Clinic-Minocqua Center
- Green Bay Oncology - Oconto Falls
- Marshfield Clinic at James Beck Cancer Center
- Saint Mary's Hospital
- Lakeview Medical Center-Marshfield Clinic
- Marshfield Clinic-Rice Lake Center
- Saint Nicholas Hospital
- Marshfield Clinic Cancer Care at Saint Michael's Hospital
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aspirus Regional Cancer Center
- Marshfield Clinic - Weston Center
- Saint Clare's Hospital
- Marshfield Clinic - Wisconsin Rapids Center
- Riverview Hospital
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.