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Spots Global Cancer Trial Database for S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

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Trial Identification

Brief Title: S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

Official Title: Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates

Study ID: NCT00109850

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mobile Infirmary Medical Center, Mobile, Alabama, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

Peninsula Medical Center, Burlingame, California, United States

Eden Medical Center, Castro Valley, California, United States

Marin Cancer Institute at Marin General Hospital, Greenbrae, California, United States

Sutter Health - Western Division Cancer Research Group, Greenbrae, California, United States

Saint Rose Hospital, Hayward, California, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

Highland General Hospital, Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States

CCOP - Bay Area Tumor Institute, Oakland, California, United States

Desert Regional Medical Center Comprehensive Cancer Center, Palm Springs, California, United States

Valley Care Medical Center, Pleasanton, California, United States

University of California Davis Cancer Center, Sacramento, 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

CCOP - Santa Rosa Memorial Hospital, Sana Rosa, California, United States

Sutter Solano Medical Center, Vallejo, California, United States

Poudre Valley Hospital, Fort Collins, Colorado, United States

Watson Clinic, LLC, Lakeland, Florida, United States

Augusta Oncology Associates - Walton Way, Augusta, Georgia, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler, 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 - Chanute, Chanute, 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

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, 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

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, 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

Wesley Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States

Mecosta County Medical Center, Big Rapids, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States

Spectrum Health Hospital - Butterworth Campus, Grand Rapids, Michigan, United States

Metro Health Hospital, 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

Hulston Cancer Center at Cox Medical Center South, 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. 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. James Healthcare Cancer Care, Butte, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

, Great Falls, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Glacier Oncology, PLLC, Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Community Medical Center, Missoula, Montana, United States

Guardian Oncology and Center for Wellness, Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States

Interlakes Oncology/Hematology PC, Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley 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

Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

Middletown Regional Hospital, Middletown, 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

Legacy Mount Hood Medical Center, Gresham, Oregon, United States

Providence Milwaukie Hospital, Milwaukie, Oregon, 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

CCOP - Columbia River Oncology Program, Portland, Oregon, United States

Providence St. Vincent Medical Center, 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

Oregon Health & Science University Cancer Institute, Portland, Oregon, United States

Salem Hospital Regional Cancer Care Services, Salem, Oregon, United States

Legacy Meridian Park Hospital, Tualatin, Oregon, United States

Roper St. Francis Cancer Center at Roper Hospital, Charleston, South Carolina, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

CCOP - Greenville, Greenville, South Carolina, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States

U.T. Cancer Institute at University of Tennessee Medical Center, Knoxville, Tennessee, United States

Danville Regional Medical Center, Danville, Virginia, United States

Southwest Virginia Regional Cancer Center, Norton, Virginia, United States

St. Joseph Cancer Center, Bellingham, Washington, United States

Olympic Hematology and Oncology, Bremerton, Washington, United States

Columbia Basin Hematology, Kennewick, Washington, United States

Skagit Valley Hospital Cancer Care Center, Mt. Vernon, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Harborview Medical Center, Seattle, Washington, 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

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

Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States

Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver, Washington, United States

Wenatchee Valley Medical Center, Wenatchee, Washington, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States

Contact Details

Name: Charles R. Thomas, MD

Affiliation: OHSU Knight Cancer Institute

Role: STUDY_CHAIR

Name: Charles D. Blanke, MD, FACP

Affiliation: OHSU Knight Cancer Institute

Role: STUDY_CHAIR

Name: James L. Abbruzzese, MD

Affiliation: M.D. Anderson Cancer Center

Role: STUDY_CHAIR

Name: Lisa Hammond, MD

Affiliation: The University of Texas Health Science Center at San Antonio

Role: STUDY_CHAIR

Name: Vivek Mehta, MD

Affiliation: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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