Erlotinib Prevention of Oral Cancer (EPOC)
This study will test the ability of an epidermal growth factor receptor (EGFR) inhibitor (erlotinib) to reduce the incidence of oral cancer in the high-risk setting of oral leukoplakia with LOH in two cohorts, oral IEN (Intraepithelial neoplasia) patients with LOH in 3p and/or 9p and one other specific chromosomal locus but without cancer or oral IEN patients with LOH in 3p and/or 9p associated with curatively treated oral cancer. Researchers will test this treatment in a randomized clinical trial with 2 treatment arms: Erlotinib 150mg orally each day or placebo.
The primary endpoint of the trial will be the oral cancer-free survival in patients receiving erlotinib as compared with the control or placebo group.
- The size, number, and appearance of oral IEN will be assessed and correlated with cancer risk. A > 50% reduction in the bidimensional measurements of IEN lesions is considered a treatment response. Researchers hypothesize that patients with IEN lesions and loss of heterozygosity (LOH) of the oral cavity will respond to erlotinib.
- To examine toxicity associated with erlotinib. Researchers hypothesis that patients with oral lesions will tolerate treatment with erlotinib.
- To assess a panel of molecular markers for correlations with oral cancer development in oral IEN patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Erlotinib Prevention of Oral Cancer (EPOC)|
- Oral cancer-free survival [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Balanced randomization: Erlotinib 150 mg continuous administration for 1 year.
150 mg by mouth daily
Placebo Comparator: Placebo
Balanced randomization: Placebo continuous administration for 1 year.
Tablet by mouth daily
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402779
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Texas|
|The Univeristy of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vassiliki Papadimitrakopoulou, M.D.||M.D. Anderson Cancer Center|