Know Cancer

or
forgot password

Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival at 6 Months

Outcome Time Frame:

every 3 weeks while on treatment, then every 3 months

Safety Issue:

No

Principal Investigator

Philip J. Gold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Authority:

United States: Federal Government

Study ID:

CDR0000391201

NCT ID:

NCT00096031

Start Date:

October 2004

Completion Date:

January 2010

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • stage IV esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Greenville Greenville, South Carolina  29615
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
University of California Davis Cancer Center Sacramento, California  95817
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Tod Children's Hospital - Forum Health Youngstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Veterans Affairs Medical Center - Kansas City Kansas City, Kansas  64128
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Eden Medical Center Castro Valley, California  94546
Saint Rose Hospital Hayward, California  94545
Highland General Hospital at St. George's University School of Medicine Oakland, California  94602
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
Poudre Valley Hospital Fort Collins, Colorado  80524
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Bay Regional Medical Center Bay City, Michigan  48708
Mecosta County Medical Center Big Rapids, Michigan  49307
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington  98902
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Denver Health Medical Center Denver, Colorado  80204-4507
Montrose Memorial Hospital Cancer Center Montrose, Colorado  81401
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Northeast Georgia Medical Center Gainesville, Georgia  30501
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Randolph Hospital Asheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro, North Carolina  27401
Annie Penn Cancer Center Reidsville, North Carolina  27320
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Salem Hospital Regional Cancer Care Services Salem, Oregon  97309-5014
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Oregon Health & Science University Cancer Institute Portland, Oregon  97239-3098
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Sherman Hospital Elgin, Illinois  60120-2198
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital Eden, North Carolina  27288
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529