Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer
Both
Esophageal Cancer
Trial Information
Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates
OBJECTIVES:
Primary
- Determine the 2-year overall survival of patients with previously untreated, clinically
unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the
esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the probability of objective response (confirmed and unconfirmed, complete
and partial) in patients with measurable disease treated with this regimen.
- Determine the time to progression in patients with measurable disease treated with this
regimen.
- Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of
genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g.,
UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR,
interleukin-8, and vascular endothelial growth factor) with response, time to
progression, overall survival, and toxicity in patients treated with this regimen.
(This will not be completed as this study was closed due to poor accrual.)
OUTLINE: This is a multicenter study.
Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients
also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment
repeats every 21 days for 4 courses in the absence of disease progression or unacceptable
toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily
5 days a week for 5-6 weeks (total of 28 treatments).
After completion of study treatment, patients are followed at 4 weeks and then every 3-6
months for up to 5 years after study entry.
PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous
cell carcinoma) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the
thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction
(confined to ≤ 2 cm into the gastric cardia)
- Disease confined to the esophagus or peri-esophageal soft tissue
- T4, M0 disease
- Surgically unresectable disease by esophageal endoscopic ultrasonography OR
medically unresectable disease
NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy
AND have negative cytology within the past 4 weeks
- Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical
examination within the past 4 weeks (for measurable disease) or within the past 6
weeks (for non-measurable disease)
- Tumor specimens available
- No recurrent disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- White Blood Cell (WBC) count ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
Hepatic
- Albumin normal
- Bilirubin normal
- Alkaline phosphatase normal
- Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase
(SGPT) ≤ 2.5 times upper limit of normal
Renal
- Creatinine clearance > 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior severe reaction to monoclonal antibodies
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for esophageal cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for esophageal cancer
- No concurrent intensity modulated radiotherapy
- No concurrent cobalt-60
Surgery
- No prior surgical resection or attempted surgical resection of esophageal cancer
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 2 Years
Outcome Description:
Measured from time of registration to date of death due to any cause, or last contact date
Outcome Time Frame:
0-2 years
Safety Issue:
No
Principal Investigator
Charles R. Thomas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000426442
NCT ID:
NCT00109850
Start Date:
May 2005
Completion Date:
May 2012
Related Keywords:
- Esophageal Cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- stage III 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 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| 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 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| 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 |
| 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. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | 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 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Peninsula Medical Center | Burlingame, California 94010 |
| Eden Medical Center | Castro Valley, California 94546 |
| Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
| Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
| Saint Rose Hospital | Hayward, California 94545 |
| Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
| Valley Care Medical Center | Pleasanton, California 94588 |
| California Pacific Medical Center - California Campus | San Francisco, California 94118 |
| Sutter Solano Medical Center | Vallejo, California 94589 |
| Poudre Valley Hospital | Fort Collins, Colorado 80524 |
| 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 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| 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 |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Southwest Virginia Regional Cancer Center | Norton, Virginia 24273 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Highland General Hospital | Oakland, California 94602 |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
| 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 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
| 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 |
| Billings Clinic - Downtown | Billings, Montana 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
| St. James Healthcare Cancer Care | Butte, Montana 59701 |
| Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
| Northwest Cancer Specialists at Rose Quarter Cancer Center | Portland, Oregon 97227 |
| Salem Hospital Regional Cancer Care Services | Salem, Oregon 97309-5014 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Columbia Basin Hematology | Kennewick, Washington 99336 |
| 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 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
| U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville, Tennessee 37920-2911 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
| Great Falls, Montana 59405 | |
| Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
| Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
| Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
| Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs, California 92262 |
| Watson Clinic, LLC | Lakeland, Florida 33804-5000 |
| Augusta Oncology Associates - Walton Way | Augusta, Georgia 30901 |
| Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
