Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
2 septembre 2021 mis à jour par: Alliance for Clinical Trials in Oncology
Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one chemotherapy drug (combination chemotherapy) together with cetuximab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying three different combination chemotherapy regimens to compare how well they work when given together with cetuximab in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (squamous cell carcinoma vs adenocarcinoma) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2). Patients are randomized to 1 of 3 treatment arms. For more information please see the "Arms" section which includes a detailed description of the treatment regimens.
The primary objective of the study is evaluate the tumor response rate (RR) for each of the regimens in this trial and to select the most promising regimen based on RR for further testing in patients with metastatic esophageal or GE junction adenocarcinoma. The secondary objectives are:
- To evaluate overall survival (OS) for each of the regimens in this trial in patients with metastatic esophageal or GE junction adenocarcinoma.
- To evaluate progression-free survival (PFS) for each of the regimens in this trial in patients with metastatic esophageal or GE junction adenocarcinoma.
- To evaluate time to treatment failure (TTF) for each of the regimens in this trial in patients with metastatic esophageal or GE junction adenocarcinoma.
- To determine the type and severity of toxicities associated with each of these regimens in the multi-institutional phase II setting.
- Quantitative immunohistochemistry results will be correlated with objective response rate, overall survival and time to progression.
- To evaluate the cellular damage (apoptosis) as a result of oxaliplatin.
- To determine if germline EGFR variants correlate with skin rash in patients treated with cetuximab.
- To evaluate if a correlation exists between germline EGFR variants and tumor EFGR expression as measured by immunohistochemistry.
All subjects must be premedicated with diphenhydramine hydrochloride 50 mg IV (or a similar agent) prior to the first dose of cetuximab in an effort to minimize infusion and hypersensitivity reactions. Premedication is recommended prior to subsequent doses, but the dose of diphenhydramine (or similar agent) may be reduced at the investigator's discretion. More information is detailed in the protocol including a description of the premedication requirements. Patients were closely monitored for treatment-related adverse events. After completion of study treatment, patients are followed periodically for up to 2 years.
Type d'étude
Interventionnel
Inscription (Réel)
245
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Connecticut
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Norwalk, Connecticut, États-Unis, 06856
- Norwalk Hospital
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Delaware
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Lewes, Delaware, États-Unis, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, États-Unis, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, États-Unis, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Illinois
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Aurora, Illinois, États-Unis, 60504
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, États-Unis, 61701
- St. Joseph Medical Center
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Canton, Illinois, États-Unis, 61520
- Graham Hospital
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Carthage, Illinois, États-Unis, 62321
- Memorial Hospital
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Cancer Research Center
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Decatur, Illinois, États-Unis, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Eureka, Illinois, États-Unis, 61530
- Eureka Community Hospital
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Evanston, Illinois, États-Unis, 60201-1781
- Evanston Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Clinic, PC
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Harvey, Illinois, États-Unis, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Havana, Illinois, États-Unis, 62644
- Mason District Hospital
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Hopedale, Illinois, États-Unis, 61747
- Hopedale Medical Complex
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Joliet, Illinois, États-Unis, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Macomb, Illinois, États-Unis, 61455
- Mcdonough District Hospital
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Normal, Illinois, États-Unis, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, États-Unis, 61761
- Community Cancer Center
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Ottawa, Illinois, États-Unis, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, États-Unis, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, États-Unis, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, États-Unis, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, États-Unis, 61614
- Proctor Hospital
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Peoria, Illinois, États-Unis, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, États-Unis, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, États-Unis, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, États-Unis, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, États-Unis, 61356
- Perry Memorial Hospital
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Rockford, Illinois, États-Unis, 61104-2315
- Swedish-American Regional Cancer Center
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Spring Valley, Illinois, États-Unis, 61362
- St. Margaret's Hospital
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Springfield, Illinois, États-Unis, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, États-Unis, 61801
- CCOP - Carle Cancer Center
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Indiana
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Elkhart, Indiana, États-Unis, 46515
- Elkhart General Hospital
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Fort Wayne, Indiana, États-Unis, 46845
- Fort Wayne Medical Oncology and Hematology
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Indianapolis, Indiana, États-Unis, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, États-Unis, 46202
- William N. Wishard Memorial Hospital
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Kokomo, Indiana, États-Unis, 46904
- Howard Community Hospital
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La Porte, Indiana, États-Unis, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, États-Unis, 46360
- Saint Anthony Memorial Health Centers
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South Bend, Indiana, États-Unis, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, États-Unis, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, États-Unis, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, États-Unis, 46617
- South Bend Clinic
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Iowa
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Ames, Iowa, États-Unis, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, États-Unis, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, États-Unis, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, États-Unis, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Des Moines, Iowa, États-Unis, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, États-Unis, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, États-Unis, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, États-Unis, 50307
- Mercy Capitol Hospital
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Iowa City, Iowa, États-Unis, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Mason City, Iowa, États-Unis, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, États-Unis, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, États-Unis, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, États-Unis, 51104
- Mercy Medical Center - Sioux City
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West Des Moines, Iowa, États-Unis, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kansas
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Anthony, Kansas, États-Unis, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, États-Unis, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, États-Unis, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, États-Unis, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, États-Unis, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, États-Unis, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, États-Unis, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, États-Unis, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, États-Unis, 67901
- Southwest Medical Center
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Newton, Kansas, États-Unis, 67114
- Cancer Center of Kansas, PA - Newton
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Overland Park, Kansas, États-Unis, 66209
- Menorah Medical Center
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Parsons, Kansas, États-Unis, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, États-Unis, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, États-Unis, 67042
- Cancer Center of Kansas, PA - Salina
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Shawnee Mission, Kansas, États-Unis, 66204
- Shawnee Mission Medical Center
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Wellington, Kansas, États-Unis, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, États-Unis, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, États-Unis, 67214
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, États-Unis, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, États-Unis, 67156
- Cancer Center of Kansas, PA - Winfield
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Maine
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Bangor, Maine, États-Unis, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21237
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
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Easton, Maryland, États-Unis, 21601
- Shore Regional Cancer Center at Memorial Hospital - Easton
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Elkton, Maryland, États-Unis, 21921
- Union Hospital of Cecil County
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, États-Unis, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Boston, Massachusetts, États-Unis, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Burlington, Massachusetts, États-Unis, 01805
- Lahey Clinic Medical Center - Burlington
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South Weymouth, Massachusetts, États-Unis, 02190
- South Shore Hospital
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Springfield, Massachusetts, États-Unis, 01199
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Michigan
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Ann Arbor, Michigan, États-Unis, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, États-Unis, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, États-Unis, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, États-Unis, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, États-Unis, 48503
- Hurley Medical Center
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Flint, Michigan, États-Unis, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, États-Unis, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, États-Unis, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, États-Unis, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, États-Unis, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, États-Unis, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, États-Unis, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, États-Unis, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, États-Unis, 48154
- St. Mary Mercy Hospital
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Pontiac, Michigan, États-Unis, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, États-Unis, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, États-Unis, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, États-Unis, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Saint Joseph, Michigan, États-Unis, 49085
- Oncology Care Associates, PLLC
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Warren, Michigan, États-Unis, 48093
- St. John Macomb Hospital
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Minnesota
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, États-Unis, 55805
- CCOP - Duluth
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Duluth, Minnesota, États-Unis, 55805
- Miller - Dwan Medical Center
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Duluth, Minnesota, États-Unis, 55805-1983
- Essentia Health - Duluth Clinic
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, États-Unis, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, États-Unis, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, États-Unis, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, États-Unis, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, États-Unis, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, États-Unis, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, États-Unis, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, États-Unis, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, États-Unis, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, États-Unis, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, États-Unis, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, États-Unis, 55125
- Minnesota Oncology - Woodbury
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Missouri
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Independence, Missouri, États-Unis, 64050
- Independence Regional Health Center
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Kansas City, Missouri, États-Unis, 64116
- North Kansas City Hospital
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Kansas City, Missouri, États-Unis, 64132
- Research Medical Center
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Kansas City, Missouri, États-Unis, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, États-Unis, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, États-Unis, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, États-Unis, 64116
- Parvin Radiation Oncology
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Liberty, Missouri, États-Unis, 64068
- Liberty Hospital
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Saint Joseph, Missouri, États-Unis, 64506
- Heartland Regional Medical Center
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Saint Louis, Missouri, États-Unis, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, États-Unis, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
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Nebraska
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Omaha, Nebraska, États-Unis, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, États-Unis, 68122
- Immanuel Medical Center
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Omaha, Nebraska, États-Unis, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, États-Unis, 68131-2197
- Creighton University Medical Center
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Omaha, Nebraska, États-Unis, 68114
- Methodist Estabrook Cancer Center
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Nevada
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Las Vegas, Nevada, États-Unis, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, États-Unis, 89106
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Marlton, New Jersey, États-Unis, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Newark, New Jersey, États-Unis, 07112
- Newark Beth Israel Medical Center
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Sparta, New Jersey, États-Unis, 07871
- Frederick R. and Betty M. Smith Cancer Treatment Center
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Voorhees, New Jersey, États-Unis, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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Voorhees, New Jersey, États-Unis, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
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New York
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Bronx, New York, États-Unis, 10466
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
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Buffalo, New York, États-Unis, 14215
- Veterans Affairs Medical Center - Buffalo
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East Syracuse, New York, États-Unis, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Glens Falls, New York, États-Unis, 12801
- Charles R. Wood Cancer Center at Glens Falls Hospital
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New York, New York, États-Unis, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, États-Unis, 10035
- Ralph Lauren Center for Cancer Care and Prevention
-
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, États-Unis, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, États-Unis, 27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville, North Carolina, États-Unis, 28791
- Pardee Memorial Hospital
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Kinston, North Carolina, États-Unis, 28501
- Kinston Medical Specialists
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Ohio
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Akron, Ohio, États-Unis, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Canton, Ohio, États-Unis, 44710-1799
- Aultman Cancer Center at Aultman Hospital
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Cleveland, Ohio, États-Unis, 44109
- MetroHealth Cancer Care Center at MetroHealth Medical Center
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Columbus, Ohio, États-Unis, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Lima, Ohio, États-Unis, 45801
- St. Rita's Medical Center
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Bethlehem, Pennsylvania, États-Unis, 18015
- St. Luke's Cancer Network at St. Luke's Hospital
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Danville, Pennsylvania, États-Unis, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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East Stroudsburg, Pennsylvania, États-Unis, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hazleton, Pennsylvania, États-Unis, 18201
- Geisinger Hazleton Cancer Center
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Hershey, Pennsylvania, États-Unis, 17033-0850
- Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
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Lewistown, Pennsylvania, États-Unis, 17044
- Lewistown Hospital
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Philadelphia, Pennsylvania, États-Unis, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Philadelphia, Pennsylvania, États-Unis, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, États-Unis, 19107
- Joan Karnell Cancer Center at Pennsylvania Hospital
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Philadelphia, Pennsylvania, États-Unis, 19114
- Frankford Hospital Cancer Center - Torresdale Campus
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Scranton, Pennsylvania, États-Unis, 18508
- Hematology and Oncology Associates of Northeastern Pennsylvania
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State College, Pennsylvania, États-Unis, 16803
- Mount Nittany Medical Center
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State College, Pennsylvania, États-Unis, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, États-Unis, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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Wilkes-Barre, Pennsylvania, États-Unis, 18765
- Mercy Hospital at Wilkes-Barre
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Williamsport, Pennsylvania, États-Unis, 17701
- Susquehanna Cancer Center at Divine Providence Hospital
-
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South Carolina
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Florence, South Carolina, États-Unis, 29501
- McLeod Regional Medical Center
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, États-Unis, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, États-Unis, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Kingsport, Tennessee, États-Unis, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Texas
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Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
-
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Vermont
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Berlin, Vermont, États-Unis, 05602
- Mountainview Medical
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Burlington, Vermont, États-Unis, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Danville, Virginia, États-Unis, 24541
- Danville Regional Medical Center
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Norton, Virginia, États-Unis, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Wisconsin
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Eau Claire, Wisconsin, États-Unis, 54701
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
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Eau Claire, Wisconsin, États-Unis, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
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Green Bay, Wisconsin, États-Unis, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, États-Unis, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, États-Unis, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, États-Unis, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Marinette, Wisconsin, États-Unis, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, États-Unis, 54449
- Saint Joseph's Hospital
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Milwaukee, Wisconsin, États-Unis, 53215
- Medical Consultants, Limited
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Minocqua, Wisconsin, États-Unis, 54548
- Marshfield Clinic - Lakeland Center
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Oconto Falls, Wisconsin, États-Unis, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Rhinelander, Wisconsin, États-Unis, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, États-Unis, 54868
- Marshfield Clinic - Indianhead Center
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Stevens Point, Wisconsin, États-Unis, 54481
- Saint Michael's Hospital Cancer Center
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Sturgeon Bay, Wisconsin, États-Unis, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wausau, Wisconsin, États-Unis, 54401
- Marshfield Clinic - Wausau Center
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Wausau, Wisconsin, États-Unis, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
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Weston, Wisconsin, États-Unis, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, États-Unis, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Metastatic disease of the esophagus or gastroesophageal junction
- Histologic, cytologic or radiologic documentation of metastatic squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent or locally residual (post-resection) disease is also permitted.
- For the purposes of this study, undifferentiated adenocarcinomas and adenosquamous tumors will be considered as adenocarcinomas. In addition, tumors involving the gastroesophageal junction will be defined by the Siewert classification.
Patients with gastroesophageal junction tumors who are eligible:
- AEG Type I: Adenocarcinoma of the distal esophagus which usually arises from an area with specialized intestinal metaplasia of the esophagus (eg, Barrett's esophagus, and may infiltrate the esophagogastric junction from above).
- AEG Type II: True carcinoma of the cardia arising from the cardiac epithelium or short segments with intestinal metaplasia at the esophagogastric junction.
Patients with gastroesophageal junction tumors who are NOT eligible:
- AEG Type III: Subcardial gastric carcinoma which infiltrates the esophagogastric junction and distal esophagus from below.
Patients must have at least one paraffin block available (or at least 15 unstained slides for analysis of tumor EGFR status.
- Patients with a history of esophageal and GE junction carcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease OR the primary cancer was stage I.
- Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic esophageal or GE junction carcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
- Patients with Measurable Disease - Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
Prior Treatment:
- No prior chemotherapy or radiotherapy. No prior therapy which specifically and directly targets the EGF(R) pathway.
- No prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
- Patients must have completed any major surgery ≥ 4 weeks or any minor surgery ≥ 2 weeks before registration. Patients must have fully recovered from the procedure. Insertion of a vascular access device is not considered major or minor surgery.
- No concurrent use of investigational agents is allowed while participating in this study.
Patient Characteristics:
- ECOG Performance Status of 0-2
- ≥ 18 years of age
- Patients must be documented to have a stable weight (or less than one pound weight loss) for at least one week prior to registration.
- Non-pregnant and not breast-feeding. The effects of cetuximab, cisplatin, epirubicin, fluorouracil, leucovorin, irinotecan, and oxaliplatin on a developing human fetus are not well-known. Because the risk of toxicity in nursing infants secondary to cetuximab, cisplatin, epirubicin, fluorouracil, irinotecan, and oxaliplatin treatment of the mother is unknown but may be harmful, breastfeeding must be discontinued.
- No myocardial infarction < 6 months prior to registration or New York Heart Association classification III or IV.
- No ≥ grade 2 diarrhea within 7 days prior to registration.
Patients may not concurrently have any of the following conditions:
- Known central nervous system metastases or carcinomatous meningitis
- Interstitial pneumonia or symptomatic interstitial fibrosis of the lung
- Seizure disorder or active neurological disease requiring anti-epileptic medication
- ≥ grade 2 peripheral neuropathy
- No evidence of Gilbert's Syndrome - Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38, the active metabolite of irinotecan. Evidence of Gilbert's Syndrome would include documentation of elevation of indirect bilirubin at any time in the patient's medical history.
Required Initial Laboratory Data:
- Granulocytes ≥ 1500/µl
- Platelet count ≥ 100,000/µl
- Creatinine ≤ 1.5 mg/dL
- AST (SGOT) ≤ 5.0 x Upper limits of normal
- Total bilirubin ≤ 1.5 mg/dL
- Albumin ≥ 2.5 grams/dL
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm A (ECF + cetuximab)
Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter.
Patients receive cetuximab IV on days 1, 8 and 15.
Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes.
On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion.
Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
donné IV
Autres noms:
epirubicin and 5-fluorouracil given IV
Autres noms:
|
|
Expérimental: Arm B (IC + cetuximab)
Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter.
Patients receive cetuximab on days 1, 8 and 15.
Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab.
Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
donné IV
Autres noms:
cisplatin and irinotecan given IV
Autres noms:
|
|
Expérimental: ARM C (FOLFOX + cetuximab)
Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter.
Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration.
Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours.
Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
donné IV
Autres noms:
oxaliplatin , leucovorin and 5-fluorouracil IV
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
Délai: Up to 2 years post-treatment
|
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.
|
Up to 2 years post-treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
Délai: Up to 2 years post-treatment
|
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy.
|
Up to 2 years post-treatment
|
|
Overall Survival in Patients With Adenocarcinoma
Délai: Up to 2 years post-treatment
|
Overall survival (OS) was defined as the time from study entry to death of any cause.
The median OS with 95% CI was estimated using the Kaplan Meier method.
|
Up to 2 years post-treatment
|
|
Progression-free Survival in Patients With Adenocarcinoma
Délai: Up to 2 years post-treatment
|
Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause.
The median PFS with 95% CI was estimated using the Kaplan Meier method.
|
Up to 2 years post-treatment
|
|
Time to Treatment Failure in Patients With Adenocarcinoma
Délai: Up to 2 years post-treatment
|
Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity.
The median TTF with 95% CI was estimated using the Kaplan Meier method.
|
Up to 2 years post-treatment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Peter Enzinger, MD, Dana-Farber Cancer Institute
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 septembre 2006
Achèvement primaire (Réel)
1 avril 2011
Achèvement de l'étude (Réel)
15 octobre 2014
Dates d'inscription aux études
Première soumission
26 septembre 2006
Première soumission répondant aux critères de contrôle qualité
26 septembre 2006
Première publication (Estimation)
28 septembre 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs de l'oesophage
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents protecteurs
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Agents antinéoplasiques immunologiques
- Micronutriments
- Antibiotiques, Antinéoplasiques
- Vitamines
- Inhibiteurs de la topoisomérase I
- Antidotes
- Complexe de vitamine B
- Cisplatine
- Fluorouracile
- Epirubicine
- Oxaliplatine
- Leucovorine
- Irinotécan
- Cétuximab
Autres numéros d'identification d'étude
- CALGB-80403
- ECOG-E1206
- CDR0000505535 (Autre identifiant: Physician Data Query)
- NCI-2009-00492 (Autre identifiant: NCI Clinical Trial Reporting Program)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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