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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cetuximab
ECF
IC
FOLFOX
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus, stage IV esophageal cancer, recurrent esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  1. Metastatic disease of the esophagus or gastroesophageal junction

    1. 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.
    2. 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.

    3. 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.

    4. 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.

  2. Patients must have at least one paraffin block available (or at least 15 unstained slides for analysis of tumor EGFR status.

    1. 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.
    2. 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.
  3. 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.

  4. Prior Treatment:

    1. No prior chemotherapy or radiotherapy. No prior therapy which specifically and directly targets the EGF(R) pathway.
    2. No prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
    3. 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.
    4. No concurrent use of investigational agents is allowed while participating in this study.

  5. Patient Characteristics:

    1. ECOG Performance Status of 0-2
    2. ≥ 18 years of age
    3. Patients must be documented to have a stable weight (or less than one pound weight loss) for at least one week prior to registration.
    4. 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.
  6. No myocardial infarction < 6 months prior to registration or New York Heart Association classification III or IV.
  7. No ≥ grade 2 diarrhea within 7 days prior to registration.

  8. Patients may not concurrently have any of the following conditions:

    1. Known central nervous system metastases or carcinomatous meningitis
    2. Interstitial pneumonia or symptomatic interstitial fibrosis of the lung
    3. Seizure disorder or active neurological disease requiring anti-epileptic medication
    4. ≥ grade 2 peripheral neuropathy
  9. 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.

  10. Required Initial Laboratory Data:

    1. Granulocytes ≥ 1500/µl
    2. Platelet count ≥ 100,000/µl
    3. Creatinine ≤ 1.5 mg/dL
    4. AST (SGOT) ≤ 5.0 x Upper limits of normal
    5. Total bilirubin ≤ 1.5 mg/dL
    6. Albumin ≥ 2.5 grams/dL

Sites / Locations

  • Norwalk Hospital
  • Tunnell Cancer Center at Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Rush-Copley Cancer Care Center
  • St. Joseph Medical Center
  • Graham Hospital
  • Memorial Hospital
  • University of Chicago Cancer Research Center
  • Decatur Memorial Hospital Cancer Care Institute
  • Eureka Community Hospital
  • Evanston Hospital
  • Galesburg Clinic, PC
  • Galesburg Cottage Hospital
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • Mason District Hospital
  • Hopedale Medical Complex
  • Joliet Oncology-Hematology Associates, Limited - West
  • McDonough District Hospital
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Community Hospital of Ottawa
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • Proctor Hospital
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • OSF St. Francis Medical Center
  • Illinois Valley Community Hospital
  • Perry Memorial Hospital
  • Swedish-American Regional Cancer Center
  • St. Margaret's Hospital
  • Regional Cancer Center at Memorial Medical Center
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • Elkhart General Hospital
  • Fort Wayne Medical Oncology and Hematology
  • Indiana University Melvin and Bren Simon Cancer Center
  • William N. Wishard Memorial Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Anthony Memorial Health Centers
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • South Bend Clinic
  • McFarland Clinic, PC
  • Hematology Oncology Associates of the Quad Cities
  • Cedar Rapids Oncology Associates
  • Mercy Regional Cancer Center at Mercy Medical Center
  • Mercy Capitol Hospital
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Mercy Cancer Center at Mercy Medical Center - North Iowa
  • McCreery Cancer Center at Ottumwa Regional
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Medical Oncology and Hematology Associates - West Des Moines
  • Hospital District Sixth of Harper County
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas, PA - Kingman
  • Lawrence Memorial Hospital
  • Southwest Medical Center
  • Cancer Center of Kansas, PA - Newton
  • Menorah Medical Center
  • Cancer Center of Kansas, PA - Parsons
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Shawnee Mission Medical Center
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • CancerCare of Maine at Eastern Maine Medical Center
  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
  • Shore Regional Cancer Center at Memorial Hospital - Easton
  • Union Hospital of Cecil County
  • Massachusetts General Hospital
  • Dana-Farber/Brigham and Women's Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  • Lahey Clinic Medical Center - Burlington
  • South Shore Hospital
  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Green Bay Oncology, Limited - Escanaba
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Dickinson County Healthcare System
  • Foote Memorial Hospital
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Oncology Care Associates, PLLC
  • St. John Macomb Hospital
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • Essentia Health - Duluth Clinic
  • CCOP - Duluth
  • Miller - Dwan Medical Center
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • HealthEast Cancer Care at St. John's Hospital
  • Minnesota Oncology - Maplewood
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  • Hennepin County Medical Center - Minneapolis
  • Veterans Affairs Medical Center - Minneapolis
  • Humphrey Cancer Center at North Memorial Outpatient Center
  • CCOP - Metro-Minnesota
  • Park Nicollet Cancer Center
  • Regions Hospital Cancer Care Center
  • United Hospital
  • St. Francis Cancer Center at St. Francis Medical Center
  • Ridgeview Medical Center
  • Minnesota Oncology - Woodbury
  • Independence Regional Health Center
  • Truman Medical Center - Hospital Hill
  • Saint Luke's Cancer Institute at Saint Luke's Hospital
  • St. Joseph Medical Center
  • North Kansas City Hospital
  • Parvin Radiation Oncology
  • CCOP - Kansas City
  • Research Medical Center
  • Liberty Hospital
  • Heartland Regional Medical Center
  • Missouri Baptist Cancer Center
  • Arch Medical Services, Incorporated at Center for Cancer Care and Research
  • CCOP - Missouri Valley Cancer Consortium
  • Methodist Estabrook Cancer Center
  • Immanuel Medical Center
  • Alegant Health Cancer Center at Bergan Mercy Medical Center
  • Creighton University Medical Center
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Newark Beth Israel Medical Center
  • Frederick R. and Betty M. Smith Cancer Treatment Center
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Buffalo
  • CCOP - Hematology-Oncology Associates of Central New York
  • Charles R. Wood Cancer Center at Glens Falls Hospital
  • Ralph Lauren Center for Cancer Care and Prevention
  • Memorial Sloan-Kettering Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Wayne Memorial Hospital, Incorporated
  • Pardee Memorial Hospital
  • Kinston Medical Specialists
  • Summa Center for Cancer Care at Akron City Hospital
  • Aultman Cancer Center at Aultman Hospital
  • MetroHealth Cancer Care Center at MetroHealth Medical Center
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  • St. Rita's Medical Center
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • St. Luke's Cancer Network at St. Luke's Hospital
  • Geisinger Cancer Institute at Geisinger Health
  • Dale and Frances Hughes Cancer Center at Pocono Medical Center
  • Geisinger Hazleton Cancer Center
  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
  • Lewistown Hospital
  • Abramson Cancer Center of the University of Pennsylvania
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Joan Karnell Cancer Center at Pennsylvania Hospital
  • Fox Chase Cancer Center - Philadelphia
  • Frankford Hospital Cancer Center - Torresdale Campus
  • Hematology and Oncology Associates of Northeastern Pennsylvania
  • Geisinger Medical Group - Scenery Park
  • Mount Nittany Medical Center
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • Mercy Hospital at Wilkes-Barre
  • Susquehanna Cancer Center at Divine Providence Hospital
  • McLeod Regional Medical Center
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sanford Cancer Center at Sanford USD Medical Center
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • CCOP - Scott and White Hospital
  • Mountainview Medical
  • Fletcher Allen Health Care - University Health Center Campus
  • Danville Regional Medical Center
  • Southwest Virginia Regional Cancer Center at Wellmonth Health
  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital
  • Marshfield Clinic Cancer Care at Regional Cancer Center
  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center - Green Bay
  • St. Vincent Hospital Regional Cancer Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Saint Joseph's Hospital
  • Medical Consultants, Limited
  • Marshfield Clinic - Lakeland Center
  • Green Bay Oncology, Limited - Oconto Falls
  • Ministry Medical Group at Saint Mary's Hospital
  • Marshfield Clinic - Indianhead Center
  • Saint Michael's Hospital Cancer Center
  • Green Bay Oncology, Limited - Sturgeon Bay
  • Marshfield Clinic - Wausau Center
  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  • Marshfield Clinic - Weston Center
  • Marshfield Clinic - Wisconsin Rapids Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A (ECF + cetuximab)

Arm B (IC + cetuximab)

ARM C (FOLFOX + cetuximab)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
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.

Secondary Outcome Measures

Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
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.
Overall Survival in Patients With Adenocarcinoma
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.
Progression-free Survival in Patients With Adenocarcinoma
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.
Time to Treatment Failure in Patients With Adenocarcinoma
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.

Full Information

First Posted
September 26, 2006
Last Updated
September 2, 2021
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Bristol-Myers Squibb, Sanofi, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00381706
Brief Title
Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Official Title
Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2006 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Bristol-Myers Squibb, Sanofi, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus, stage IV esophageal cancer, recurrent esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (ECF + cetuximab)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (IC + cetuximab)
Arm Type
Experimental
Arm Description
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.
Arm Title
ARM C (FOLFOX + cetuximab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
C225
Intervention Description
given IV
Intervention Type
Drug
Intervention Name(s)
ECF
Other Intervention Name(s)
Ellence (epirubicin) and 5-fluorouracil (5-FU)
Intervention Description
epirubicin and 5-fluorouracil given IV
Intervention Type
Drug
Intervention Name(s)
IC
Other Intervention Name(s)
Platinol-AQ (cisplatin), CPT-11 (irinotecan)
Intervention Description
cisplatin and irinotecan given IV
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Other Intervention Name(s)
Eloxatin (oxaliplatin), folinic acid (leucovorin), and 5-fluorouracil (5-FU)
Intervention Description
oxaliplatin , leucovorin and 5-fluorouracil IV
Primary Outcome Measure Information:
Title
Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
Description
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.
Time Frame
Up to 2 years post-treatment
Secondary Outcome Measure Information:
Title
Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
Description
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.
Time Frame
Up to 2 years post-treatment
Title
Overall Survival in Patients With Adenocarcinoma
Description
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.
Time Frame
Up to 2 years post-treatment
Title
Progression-free Survival in Patients With Adenocarcinoma
Description
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.
Time Frame
Up to 2 years post-treatment
Title
Time to Treatment Failure in Patients With Adenocarcinoma
Description
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.
Time Frame
Up to 2 years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Enzinger, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
St. Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Ingalls Cancer Care Center at Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
St. Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
William N. Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Hematology Oncology Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Cedar Rapids Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Capitol Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at Mercy Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
McCreery Cancer Center at Ottumwa Regional
City
Ottumwa
State/Province
Iowa
ZIP/Postal Code
52501
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Medical Oncology and Hematology Associates - West Des Moines
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Hospital District Sixth of Harper County
City
Anthony
State/Province
Kansas
ZIP/Postal Code
67003
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Shawnee Mission Medical Center
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
CancerCare of Maine at Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Shore Regional Cancer Center at Memorial Hospital - Easton
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lahey Clinic Medical Center - Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
South Shore Hospital
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Green Bay Oncology, Limited - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Dickinson County Healthcare System
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Oncology Care Associates, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Essentia Health - Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805-1983
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller - Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Minnesota Oncology - Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Francis Cancer Center at St. Francis Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Minnesota Oncology - Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Independence Regional Health Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64050
Country
United States
Facility Name
Truman Medical Center - Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Luke's Cancer Institute at Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Parvin Radiation Oncology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Liberty Hospital
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Arch Medical Services, Incorporated at Center for Cancer Care and Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegant Health Cancer Center at Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Frederick R. and Betty M. Smith Cancer Treatment Center
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Charles R. Wood Cancer Center at Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Ralph Lauren Center for Cancer Care and Prevention
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Aultman Cancer Center at Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
MetroHealth Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
St. Luke's Cancer Network at St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Dale and Frances Hughes Cancer Center at Pocono Medical Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Facility Name
Geisinger Hazleton Cancer Center
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Joan Karnell Cancer Center at Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Frankford Hospital Cancer Center - Torresdale Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Hematology and Oncology Associates of Northeastern Pennsylvania
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18508
Country
United States
Facility Name
Geisinger Medical Group - Scenery Park
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Mercy Hospital at Wilkes-Barre
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18765
Country
United States
Facility Name
Susquehanna Cancer Center at Divine Providence Hospital
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17701
Country
United States
Facility Name
McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37662
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Mountainview Medical
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Southwest Virginia Regional Cancer Center at Wellmonth Health
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Marshfield Clinic Cancer Care at Regional Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Saint Joseph's Hospital
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical Consultants, Limited
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Marshfield Clinic - Lakeland Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Green Bay Oncology, Limited - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Ministry Medical Group at Saint Mary's Hospital
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
Marshfield Clinic - Indianhead Center
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Saint Michael's Hospital Cancer Center
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Marshfield Clinic - Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Marshfield Clinic - Weston Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Enzinger PC, Burtness B, Hollis D, et al.: CALGB 80403/ECOG 1206: A randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer. [Abstract] J Clin Oncol 28 (Suppl 15): A-4006, 2010.
Results Reference
result
PubMed Identifier
27382098
Citation
Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB 3rd, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. J Clin Oncol. 2016 Aug 10;34(23):2736-42. doi: 10.1200/JCO.2015.65.5092. Epub 2016 Jul 5.
Results Reference
derived

Learn more about this trial

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

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