Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor
Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers|
- Effect on cells and patient response to study medications and assess the side effects of these medications. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Evaluate chemicals in the cells that may tell how the drug works, before and after receiving the study medications. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Drug: Erlotinib & Celecoxib
Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months.
Other Name: OSI-774, Tarceva
The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.
Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314262
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Dong Shin, MD||Emory University Winship Cancer Institute|