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S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00096031
First received: November 9, 2004
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.


Condition Intervention Phase
Esophageal Cancer
Biological: cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2004
Study Completion Date: January 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Biological: cetuximab
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other Name: Erbitux

Detailed Description:

OBJECTIVES:

  • Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
  • Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of 1 of the following sites:

    • Thoracic esophagus, located > 20 cm* from the incisors
    • Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: *Tumors located < 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
  • Disease confined to the esophagus and periesophageal soft tissue
  • Metastatic disease
  • Measurable disease by x-ray, scanning, or physical examination
  • Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease

    • One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine ≤ 1.5 times upper limit of normal

Other

  • No prior allergic reaction to chimerized or murine monoclonal antibodies
  • No evidence of human anti-mouse antibodies (HAMA)
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior cetuximab

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • At least 3 weeks since prior thoraco-abdominal surgery and recovered

Other

  • No other prior therapy that specifically targets the epidermal growth factor pathway
  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096031

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Alaska
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Eden Medical Center
Castro Valley, California, United States, 94546
Saint Rose Hospital
Hayward, California, United States, 94545
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Highland General Hospital at St. George's University School of Medicine
Oakland, California, United States, 94602
Valley Care Medical Center
Pleasanton, California, United States, 94588
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
Denver Health Medical Center
Denver, Colorado, United States, 80204
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States, 81401
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Georgia
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Piedmont Hospital
Atlanta, Georgia, United States, 30309
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States, 31603
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Sherman Hospital
Elgin, Illinois, United States, 60120
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Veterans Affairs Medical Center - Kansas City
Kansas City, Kansas, United States, 64128
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Metro Health Hospital
Grand Rapids, Michigan, United States, 49506
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Holland Community Hospital
Holland, Michigan, United States, 49423
Hackley Hospital
Muskegon, Michigan, United States, 49442
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
St. Vincent Healthcare
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
St. James Community Hospital
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59801
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New York
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203-5400
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, United States, 27288
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Dayton, Ohio, United States, 45429
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States, 97309-5014
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Philip J. Gold, MD Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Study Chair: Syma Iqbal, MD University of Southern California
  More Information

Additional Information:
Publications:
Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00096031     History of Changes
Other Study ID Numbers: CDR0000391201, S0415, U10CA032102
Study First Received: November 9, 2004
Results First Received: April 4, 2012
Last Updated: April 4, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the esophagus
recurrent esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014