drugset / Trial / NCT00402779
Erlotinib Prevention of Oral Cancer (EPOC)
Phase 3
Completed
303 enrolled
M.D. Anderson Cancer Center
Astellas Pharma US, Inc. · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The goal of this clinical research study is to learn if erlotinib hydrochloride (Tarcevaâ (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in the mouth. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body.
Timeline
- Start
- 2006-11-03
- Primary completion
- 2018-06-04
- Completion
- 2018-06-04
Outcome
Missed primary endpoint
paper The 3-year CFS rates in placebo- and erlotinib-treated patients were 74% and 70%, respectively (hazard ratio [HR], 1.27; 95% CI, 0.68-2.38; P = .45). PMID 26540028 ↗
paper Erlotinib did not, however, improve CFS in high-risk patients with LOH-positive or high-EGFR-gene-copy-number OPLs. PMID 26540028 ↗
Publications
- William WN Jr, Papadimitrakopoulou V, Lee JJ, Mao L, Cohen EE, Lin HY, Gillenwater AM, Martin JW, Lingen MW, Boyle JO, Shin DM, Vigneswaran N, Shinn N, Heymach JV, Wistuba II, Tang X, Kim ES, Saintigny P, Blair EA, Meiller T, Gutkind JS, Myers J, El-Naggar A, Lippman SM. Erlotinib and the Risk of Oral Cancer: The Erlotinib Prevention of Oral Cancer (EPOC) Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):209-16. doi: 10.1001/jamaoncol.2015.4364.
- Scully C. Challenges in predicting which oral mucosal potentially malignant disease will progress to neoplasia. Oral Dis. 2014 Jan;20(1):1-5. doi: 10.1111/odi.12208.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |