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)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate with cetuximab and concurrent thoracic radiotherapy for patients with locally advanced NSCLC
approx. 5 years
Yes
Athanassios Argiris, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
UPCI 05-106
NCT00492206
June 2006
February 2012
Name | Location |
---|---|
Emory Winship Cancer Institute | Atlanta, Georgia 30322 |
UPMC Cancer Center - Clairton | Clairton, Pennsylvania 15025 |
Sylvester Comprehensive Cancer Center, University of Miami | Miami, Florida 33136 |
Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore, Maryland 21231 |
UPMC Cancer Center -Teramana Cancer Center | Steubenville, Ohio 43952 |
UPMC Cancer Center -Beaver | Beaver, Pennsylvania 15009 |
UPMC Cancer Center -Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center - Oakbrook Commons | Greensburg, Pennsylvania 15601 |
Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
UPMC Cancer Center -Indiana | Indiana, Pennsylvania 15701 |
UPMC Cancer Center -John P. Murtha Pavilion | Johnstown, Pennsylvania 15901 |
UPMC Cancer Center -McKeesport | McKeesport, Pennsylvania 15132 |
UPMC Cancer Center -Mosside Blvd. | Monroeville, Pennsylvania 15146 |
UPMC Cancer Center -Haymaker Rd. | Monroeville, Pennsylvania 15146 |
UPMC Cancer Center -Sewickley Medical Center | Moon Township, Pennsylvania 15108 |
UPMC Cancer Center -Mt. Pleasant | Mt. Pleasant, Pennsylvania 15666 |
UPMC Cancer Center -New Castle | New Castle, Pennsylvania 16105 |
UPMC Cancer Center -Jameson | New Castle, Pennsylvania 16105 |
Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |
UPMC Cancer Center -Passavant | Pittsburgh, Pennsylvania 15237 |
UPMC Presbyterian -Radiation Oncology | Pittsburgh, Pennsylvania 15213 |
UPMC Cancer Center -Drake | Pittsburgh, Pennsylvania 15241 |
UPMC Cancer Center -Delafield Rd. | Pittsburgh, Pennsylvania 15215 |
UPMC Cancer Center -St. Clair | Pittsburgh, Pennsylvania 15243 |
UPMC Cancer Center -UPMC Shadyside | Pittsburgh, Pennsylvania 15232 |
UPMC Cancer Center -St. Margaret | Pittsburgh, Pennsylvania 15215 |
UPMC Cancer Center -UPMC Northwest | Seneca, Pennsylvania 16346 |
UPMC Cancer Center -Robert Eberly Pavilion | Uniontown, Pennsylvania 15401 |
UPMC Cancer Center -Uniontown | Uniontown, Pennsylvania 15401 |
UPMC Cancer Center -Washington | Washington, Pennsylvania 15301 |
UPMC Cancer Center -Wexford | Wexford, Pennsylvania 15090 |