Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer
Both
Esophageal Cancer
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 |
