Spots Global Cancer Trial Database for Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer
Official Title: A Randomized Phase II Study of Radiation Therapy, Pemetrexed and Carboplatin With or Without Cetuximab in Stage III Non-Small Cell Lung Cancer
Study ID: NCT00117962
Conditions
Study Description
Brief Summary: RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, 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. 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 make tumor cells more sensitive to radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and carboplatin together with radiation therapy with or without cetuximab works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed Description: OBJECTIVES: Primary * Determine the overall survival of patients with unresectable stage III non-small cell lung cancer treated with pemetrexed disodium, carboplatin, and thoracic radiotherapy with or without cetuximab. Secondary * Determine the failure-free survival and response rates in patients treated with these regimens. * Correlate epidermal growth factor receptor, erbB2, and K-ras mutations with survival and tumor response in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. * Chemoradiotherapy (courses 1-4): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. * Arm II: Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43. * Consolidation chemotherapy (courses 5-8): Beginning 3-5 weeks after completion of chemoradiotherapy, all patients receive consolidation chemotherapy comprising pemetrexed disodium alone IV over 10 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 10-13 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arroyo Grande Community Hospital, Arroyo Grande, California, United States
Eden Medical Center, Castro Valley, California, United States
Saint Rose Hospital, Hayward, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, 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
Valley Care Medical Center, Pleasanton, California, United States
Doctors Medical Center - San Pablo Campus, San Pablo, California, United States
Bendheim Cancer Center at Greenwich Hospital, Greenwich, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
La Grange Memorial Hospital, La Grange, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
Iowa Blood and Cancer Care, Cedar Rapids, Iowa, United States
St. Luke's Hospital, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Upper Chesapeake Medical Center, Bel Air, Maryland, United States
Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research, Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis, St Louis, Missouri, United States
St. Anthony's Cancer Center, St. Louis, Missouri, United States
Missouri Baptist Cancer Center, St. Louis, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island, Nebraska, United States
Callahan Cancer Center at Great Plains Regional Medical Center, North Platte, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Lakes Region General Hospital, Laconia, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital, Manchester, New Hampshire, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, United States
Mount Sinai Medical Center, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Cancer Care Associates - Mercy Campus, Oklahoma City, Oklahoma, United States
Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States
Miriam Hospital, Providence, Rhode Island, United States
Roper St. Francis Cancer Center at Roper Hospital, Charleston, South Carolina, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States
Mountainview Medical, Berlin, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Danville Regional Medical Center, Danville, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton, Virginia, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center, Huntington, West Virginia, United States
Contact Details
Name: Ramaswamy Govindan, MD
Affiliation: Washington University School of Medicine
Role: STUDY_CHAIR
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