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Brief Title: Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Official Title: A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
Study ID: NCT00153803
Brief Summary: This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Detailed Description: The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Birmingham Hematology and Oncology Associates, LLC, Birmingham, Alabama, United States
Oncology Specialties, P.C., Huntsville, Alabama, United States
Cooper Clinic, Fort Smith, Arkansas, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Northstate Cancer Speciality, Redding, California, United States
Mercy General Hospital, Sacramento, California, United States
St. Francis Hospital Cancer Center, Hartford, Connecticut, United States
Connecticut Oncology Group, Middletown, Connecticut, United States
George Bray Cancer Center/New Britain General Hospital, New Britain, Connecticut, United States
Oncology and Hematology Associates, PC, New London, Connecticut, United States
Whittingham Cancer Center at Norwalk Hospital, Norwalk, Connecticut, United States
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center, Stamford, Connecticut, United States
Washington Cancer Institute, Washington, District of Columbia, United States
Pasco Hernando Oncology Associates, Brooksville, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Lee Cancer Clinic, Fort Myers, Florida, United States
Jupiter Medical Center, Jupiter, Florida, United States
Cancer Care of North Florida, Lake City, Florida, United States
Pasco/Hernando Oncology, New Port Richey, Florida, United States
Mid Florida Oncology, Orange City, Florida, United States
MD Anderson, Orlando, Florida, United States
Oncology & Hematology Association of West Broward, Tamarac, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Alexian Brothers Hospital Network, Elk Grove Village, Illinois, United States
Joliet Hematology Associates, Joliet, Illinois, United States
Investigative Clinical Research of Indiana LLC, Indianapolis, Indiana, United States
Howard Regional Health System, Kokomo, Indiana, United States
McFarland Clinic, Ames, Iowa, United States
Kentucky Cancer Clinic, Hazard, Kentucky, United States
Western Hematology Oncology, Paducah, Kentucky, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Union Memorial Hospital, Baltimore, Maryland, United States
Harbor View Cancer Center, Baltimore, Maryland, United States
Franklin Square Hospital Center, Baltimore, Maryland, United States
Frederick Smith, MD, Chevy Chase, Maryland, United States
Community Hematology Oncology, Olney, Maryland, United States
Lahey Clinic Medical Center, Burlington, Massachusetts, United States
Fallon Clinic Hematology/ Oncology, Worcester, Massachusetts, United States
Bay Medical Cancer Center, Bay City, Michigan, United States
Southeast Nebraska Hematology/Oncology, Lincoln, Nebraska, United States
Methodist Cancer Center, Omaha, Nebraska, United States
Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Dartmouth-Hitchcock-Keene, Keene, New Hampshire, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
The Center for Cancer and Hematologic Disease, Cherry Hill, New Jersey, United States
Sussex County Medical Associates, Newton, New Jersey, United States
Lincoln Hospital, Bronx, New York, United States
Queens Medical Associates, Fresh Meadows, New York, United States
Winthrop University Hospital, Mineola, New York, United States
Hematology Oncology Associates of Rockland, PC, New York, New York, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
Aultman Cancer Center, Canton, Ohio, United States
The Cleveland Clinic Foundation Hematology/Med Oncology, Cleveland, Ohio, United States
Legacy Good Samaritan, Portland, Oregon, United States
SCOA-SC Onc Assoc, Columbia, South Carolina, United States
VA Department of Hematology/Oncology, Houston, Texas, United States
Hope Oncology, Richardson, Texas, United States
Blood and Cancer Center of East Texas, Tyler, Texas, United States
Tyler Hematology/Oncology, Tyler, Texas, United States
Veterans Administration Medical Center, White River Junction, Vermont, United States
Virginia Oncology Associates Research Program, Newport News, Virginia, United States
Olympic Hematology/Oncology, Bremerton, Washington, United States
Morgantown Internal Medicine Group, Morgantown, West Virginia, United States
Name: James R Rigas, MD
Affiliation: Norris Cotton Cancer Center
Role: STUDY_CHAIR