S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Registration Number
- NCT00109850
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: 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. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment cetuximab Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3. Treatment cisplatin Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3. Treatment irinotecan hydrochloride Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3. Treatment radiation therapy Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
- Primary Outcome Measures
Name Time Method Overall Survival at 2 Years 0-2 years Measured from time of registration to date of death due to any cause, or last contact date
- Secondary Outcome Measures
Name Time Method Progression Free Survival 0 - 5 years Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Patients were assessed for adverse events after every two cycles of chemotherapy. Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Objective Response (Confirmed and Unconfined, Complete and Partial) at week 16, then every 3 months until progression Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
Trial Locations
- Locations (131)
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Augusta Oncology Associates - Walton Way
🇺🇸Augusta, Georgia, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Sutter Health - Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Marin Cancer Institute at Marin General Hospital
🇺🇸Greenbrae, California, United States
Saint Rose Hospital
🇺🇸Hayward, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
California Pacific Medical Center - California Campus
🇺🇸San Francisco, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Sutter Solano Medical Center
🇺🇸Vallejo, California, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
U.T. Cancer Institute at University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Northwest Cancer Specialists at Vancouver Cancer Center
🇺🇸Vancouver, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Watson Clinic, LLC
🇺🇸Lakeland, Florida, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Northwest Cancer Specialists at Rose Quarter Cancer Center
🇺🇸Portland, Oregon, United States
Salem Hospital Regional Cancer Care Services
🇺🇸Salem, Oregon, United States
Roper St. Francis Cancer Center at Roper Hospital
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Southwest Virginia Regional Cancer Center
🇺🇸Norton, Virginia, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Desert Regional Medical Center Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Sana Rosa, California, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Oregon Health & Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States