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Brief Title: Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
Official Title: A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT00492206
Brief Summary: This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.
Detailed Description: This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
UPMC Cancer Center -Teramana Cancer Center, Steubenville, Ohio, United States
UPMC Cancer Center -Beaver, Beaver, Pennsylvania, United States
UPMC Cancer Center - Clairton, Clairton, Pennsylvania, United States
UPMC Cancer Center - Oakbrook Commons, Greensburg, Pennsylvania, United States
UPMC Cancer Center -Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC Cancer Center -Indiana, Indiana, Pennsylvania, United States
UPMC Cancer Center -John P. Murtha Pavilion, Johnstown, Pennsylvania, United States
UPMC Cancer Center -McKeesport, McKeesport, Pennsylvania, United States
UPMC Cancer Center -Haymaker Rd., Monroeville, Pennsylvania, United States
UPMC Cancer Center -Mosside Blvd., Monroeville, Pennsylvania, United States
UPMC Cancer Center -Sewickley Medical Center, Moon Township, Pennsylvania, United States
UPMC Cancer Center -Mt. Pleasant, Mt. Pleasant, Pennsylvania, United States
UPMC Cancer Center -Jameson, New Castle, Pennsylvania, United States
UPMC Cancer Center -New Castle, New Castle, Pennsylvania, United States
UPMC Presbyterian -Radiation Oncology, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -Delafield Rd., Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -St. Margaret, Pittsburgh, Pennsylvania, United States
Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -UPMC Shadyside, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -Passavant, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -Drake, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -St. Clair, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center -UPMC Northwest, Seneca, Pennsylvania, United States
UPMC Cancer Center -Robert Eberly Pavilion, Uniontown, Pennsylvania, United States
UPMC Cancer Center -Uniontown, Uniontown, Pennsylvania, United States
UPMC Cancer Center -Washington, Washington, Pennsylvania, United States
UPMC Cancer Center -Wexford, Wexford, Pennsylvania, United States
Name: Athanassios Argiris, MD
Affiliation: University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR