Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	CALGB-80403 ECOG-E1206, NCT00381706

Objectives

Primary

1. Compare the tumor response rate in patients with metastatic esophageal or gastroesophageal junction cancer treated with epirubicin hydrochloride, cisplatin, fluorouracil, and cetuximab (ECF-C); irinotecan hydrochloride, cisplatin, and cetuximab (IC-C); or fluorouracil, oxaliplatin, leucovorin calcium, and cetuximab (FOLFOX-C).

Secondary

1. Compare overall survival of patients treated with these regimens.
2. Compare progression-free survival of patients treated with these regimens.
3. Compare treatment failure in patients treated with these regimens.
4. Determine the type and severity of toxicities associated with these regimens in the multi-institutional phase II setting.
5. Correlate quantitative immunohistochemistry results with objective response rate, overall survival, and time to progression in these patients.
6. Evaluate the cellular damage (i.e., apoptosis) as a result of oxaliplatin in these patients.
7. Determine if germline epidermal growth factor receptor (EGFR) variants correlate with skin rash in patients treated with cetuximab.
8. Correlate germline EGFR variants with tumor EGFR expression as measured by immunohistochemistry.

Entry Criteria

Disease Characteristics:

• Histologically, cytologically, or radiologically confirmed esophageal cancer, including any of the following types:
  • Squamous cell carcinoma
  • Adenocarcinoma* of the esophagus
  • Adenocarcinoma* of the gastroesophageal (GE) junction according to Siewert classification
    • Type I or II disease
      • No type III disease

   [Note: Undifferentiated adenocarcinoma and adenosquamous tumor will be considered as adenocarcinoma]

• Metastatic disease or locally recurrent or residual (post-resection) disease
  • Resected esophageal or GE junction disease that develops radiological or clinical evidence of metastatic disease does not require histological or cytological confirmation of metastatic disease unless 1 of the following is true:
    • More than 5 years since primary surgery and development of metastatic disease
    • Primary cancer was stage I
• Measurable disease, defined as at least 1 unidimensionally measurable lesion (longest diameter) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have ≥ 1 paraffin block (or ≥ 15 unstained slides) available for analysis of tumor epidermal growth factor receptor (EGFR) status
• No known CNS metastases or carcinomatous meningitis

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior chemotherapy or radiotherapy
• No prior therapy that specifically and directly targets the EGFR pathway
• At least 4 weeks since prior major surgery* and recovered
• At least 2 weeks since prior minor surgery* and recovered
• No concurrent palliative radiotherapy
• No other concurrent investigational agent
• No other concurrent chemotherapy
• No concurrent hormonal therapy except for the following:
  • Steroids given temporarily for adrenal failure
  • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
  • Intermittent steroids (e.g., dexamethasone) as an antiemetic

 [Note: *Insertion of a vascular device is not considered major or minor surgery]

Patient Characteristics:

• ECOG performance status 0-2
• Platelet count ≥ 100,000/mm³
• Granulocyte count ≥ 1,500/mm³
• Creatinine ≤ 1.5 mg/dL
• AST ≤ 5.0 times upper limit of normal
• Bilirubin ≤ 1.5 mg/dL
• Albumin ≥ 2.5 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Must have a stable weight loss of (i.e., < 1 pound weight loss during the past week)
• No diarrhea ≥ grade 2 within the past 7 days
• No myocardial infarction within the past 6 months
• No New York Heart Association class III or IV congestive heart failure
• No interstitial pneumonia or symptomatic interstitial fibrosis of the lung
• No seizure disorder or active neurological disease requiring anti-epileptic medication
• No peripheral neuropathy ≥ grade 2
• No evidence of Gilbert's syndrome
• No prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA)

Expected Enrollment

A total of 270 patients will be accrued for this study.

Outcomes

Tumor response rate (complete and partial) in patients with measurable esophageal or GE junction adenocarcinoma
Tumor response rate (complete and partial) in patients with adenocarcinoma who have received at least 1 treatment course as measured by RECIST criteria

Tumor response rate (complete and partial) in patients with squamous cell carcinoma
Overall survival
Progression-free survival
Time to treatment failure

Outline

This is a randomized, multicenter study. Patients are stratified according to histology (squamous cell carcinoma vs adenocarcinoma) and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 3 treatment arms.

• Arm I (ECF + cetuximab): Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; epirubicin hydrochloride IV followed by cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-21. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
• Arm II (IC + cetuximab): Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV over 30 minutes followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
• ARM III (FOLFOX + cetuximab): Patients receive cetuximab IV over 1-2 hours on days 1 and 8; oxaliplatin IV over 2 hours followed by leucovorin calcium IV over 2 hours on day 1; and fluorouracil IV continuously over 46-48 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor sample collection at baseline to examine quantitative immunofluorescence with subcellular localization for epidermal growth factor receptor (EGFR), phospho EGFR, HER-2, phospho-HER-2, HER-3, HER-4, FEF, AKT, phospho AKT, PTEN, gastrin-releasing peptide (GRP), and GRP receptor levels. Tumor samples are collected at baseline from patients randomized to arm III to evaluate molecular mechanisms for correlative studies. Cellular damage (i.e., apoptosis) by oxaliplatin is determined by DNA fragmentation by TUNEL assay.

After completion of study treatment, patients are followed periodically for up to 2 years.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Peter Enzinger, MD, Protocol chair		Ph: 617-632-6855; 866-790-4500
David Ilson, MD, PhD, Protocol co-chair		Ph: 212-639-8306; 800-525-2225

Eastern Cooperative Oncology Group

Barbara Burtness, MD, Protocol chair		Ph: 215-728-3023; 888-369-2427

U.S.A.
Connecticut
	Norwalk
	Norwalk Hospital
		Richard Frank, MD	Ph:  203-845-2132
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Illinois
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3019
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Evanston
	Evanston Hospital
		Clinical Trials Office - Evanston Hospital	Ph:  847-570-1381
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3605
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-6747
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3605
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3019
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3605
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	William N. Wishard Memorial Hospital
		Patrick Loehrer, MD	Ph:  317-278-7418
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3019
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend Clinic
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Bettendorf
	Hematology Oncology Associates of the Quad Cities
		Shobha Chitneni, MD, MBBS	Ph:  563-355-7733
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Martin Wiesenfeld, MD	Ph:  319-363-8303
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Mercy Capitol Hospital
		Robert Behrens	Ph:  515-643-1000
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
	West Des Moines
	Medical Oncology and Hematology Associates - West Des Moines
		Robert Behrens	Ph:  515-875-9713
Kansas
	Anthony
	Hospital District Sixth of Harper County
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
Maryland
	Baltimore
	Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
		Clinical Trials Office - Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Ph:  443-777-7364
	Easton
	Shore Regional Cancer Center at Memorial Hospital - Easton
		Mary DeShields, MD	Ph:  410-819-3332
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Stephen Grubbs, MD	Ph:  302-366-1200
Massachusetts
	Boston
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Peter Enzinger	Ph:  617-632-3474 866-790-4500
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
	Burlington
	Lahey Clinic Medical Center - Burlington
		Clinical Trials Office - Lahey Clinic Medical Center - Burlington	Ph:  781-744-8027
	South Weymouth
	South Shore Hospital
		Peter Enzinger	Ph:  781-340-8000
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		John McCann, MD	Ph:  413-794-3316
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Gerald Bayer, MD	Ph:  920-432-6049
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Iron Mountain
	Dickinson County Healthcare System
		Gerald Bayer, MD	Ph:  920-432-6049
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Saint Joseph
	Oncology Care Associates, PLLC
		Eric Lester, MD	Ph:  269-985-0029
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Lichfield
	Meeker County Memorial Hospital
		Clinical Trials Office - Meeker County Memorial Hospital	Ph:  320-693-4520
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Veterans Affairs Medical Center - Minneapolis
		Clinical Trials Office - Veterans Affairs Medical Center - Minneapolis	Ph:  612-467-2800
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Missouri
	Independence
	Independence Regional Health Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Liberty
	Liberty Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	Arch Medical Services, Incorporated at Center for Cancer Care and Research
		Alan Lyss, MD	Ph:  314-996-5514
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5514
Nebraska
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center	Ph:  402-398-6060
	CCOP - Missouri Valley Cancer Consortium
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Creighton University Medical Center
		Clinical Trials Office - Creighton University Medical Center	Ph:  402-280-4100
	Immanuel Medical Center
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Methodist Estabrook Cancer Center
		Robert Langdon, MD	Ph:  402-399-8762
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-384-0013
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	Newark
	Newark Beth Israel Medical Center
		Clinical Trials Office - Newark Beth Israel Medical Center	Ph:  973-926-3136
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Rodwige Desnoyers	Ph:  973-726-4180
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Michael Entmacher, MD	Ph:  609-702-1900
New York
	Bronx
	Our Lady of Mercy Medical Center Comprehensive Cancer Center
		Peter Wiernik, MD	Ph:  718-304-7200
	Buffalo
	Veterans Affairs Medical Center - Buffalo
		Lynn Steinbrenner, MD	Ph:  716-862-3191
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Glens Falls
	Charles R. Wood Cancer Center at Glens Falls Hospital
		Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital	Ph:  518-926-6700
	New York
	Memorial Sloan-Kettering Cancer Center
		Minaxi Jhawer	Ph:  212-639-8895 800-525-2225
	Ralph Lauren Center for Cancer Care and Prevention
		Minaxi Jhawer	Ph:  212-987-1777
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Eliot Friedman, MD	Ph:  610-402-0512
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Sanjiv Agarwala, MD	Ph:  610-954-2145
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	East Stroudsburg
	Dale and Frances Hughes Cancer Center at Pocono Medical Center
		Rodwige Desnoyers	Ph:  570-476-3488
	Hazleton
	Geisinger Hazleton Cancer Center
		Albert Bernath, MD	Ph:  570-214-9290
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Lewistown
	Lewistown Hospital
		Yixing Jiang	Ph:  717-242-7143
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Frankford Hospital Cancer Center - Torresdale Campus
		Allen Terzian, MD	Ph:  215-612-5250
	Joan Karnell Cancer Center at Pennsylvania Hospital
		Bernard Mason, MD	Ph:  215-829-6088
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Scranton
	Hematology and Oncology Associates of Northeastern Pennsylvania
		Rodwige Desnoyers	Ph:  570-342-3675
	State College
	Geisinger Medical Group - Scenery Park
		Albert Bernath, MD	Ph:  570-214-9290
	Mount Nittany Medical Center
		Yixing Jiang	Ph:  814-231-7000
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
	Mercy Hospital at Wilkes-Barre
		Albert Bernath, MD	Ph:  570-214-9290
	Williamsport
	Susquehanna Cancer Center at Divine Providence Hospital
		Warren Robinson, Jr.	Ph:  570-326-8000
South Carolina
	Florence
	McLeod Regional Medical Center
		Clinical Trials Office - McLeod Regional Medical Center	Ph:  843-679-7256
South Dakota
	Sioux Falls
	Avera Cancer Institute
		Loren Tschetter, MD	Ph:  605-328-8000
	Medical X-Ray Center, PC
		Loren Tschetter, MD	Ph:  605-328-8000
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Kingsport
	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
		Clinical Trials Office - Christine LaGuardia Phillips Cancer Center	Ph:  423-224-5593
Texas
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
Vermont
	Berlin
	Mountainview Medical
		Steven Ades	Ph:  802-223-6196
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
	Norton
	Southwest Virginia Regional Cancer Center at Wellmonth Health
		Malcolm Mathews, MD	Ph:  423-224-3150
Wisconsin
	Eau Claire
	Center for Cancer Treatment & Prevention at Sacred Heart Hospital
		Adedayo Onitilo	Ph:  715-839-3956 800-839-3956
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Adedayo Onitilo	Ph:  715-387-5426
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Gerald Bayer, MD	Ph:  920-432-6049
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Gerald Bayer, MD	Ph:  920-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Gerald Bayer, MD	Ph:  920-432-6049
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Gerald Bayer, MD	Ph:  920-432-6049
	Marshfield
	Saint Joseph's Hospital
		Adedayo Onitilo	Ph:  715-387-1713
	Milwaukee
	Medical Consultants, Limited
		Jonathan Treisman, MD	Ph:  414-385-3086
	Minocqua
	Marshfield Clinic - Lakeland Center
		Adedayo Onitilo	Ph:  715-358-1000 800-347-0673
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Gerald Bayer, MD	Ph:  920-432-6049
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Adedayo Onitilo	Ph:  715-361-4700 800-866-8673
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Adedayo Onitilo	Ph:  715-236-8100
	Stevens Point
	Saint Michael's Hospital Cancer Center
		Adedayo Onitilo	Ph:  715-346-5000 800-472-9449
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Gerald Bayer, MD	Ph:  920-432-6049
	Wausau
	Marshfield Clinic - Wausau Center
		Adedayo Onitilo	Ph:  715-847-3000 800-847-0016
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
	Weston
	Marshfield Clinic - Weston Center
		Adedayo Onitilo	Ph:  715-393-1000 888-782-8581
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Adedayo Onitilo	Ph:  715-424-8600

Registry Information
Official Title		Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer
Trial Start Date		2006-09-15
Trial Completion Date		2008-07-21 (estimated)
Registered in ClinicalTrials.gov		NCT00381706
Date Submitted to PDQ		2006-08-18
Information Last Verified		2009-06-03
NCI Grant/Contract Number		CA31946

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