A Phase 1 interventional study of Erlotinib and Celecoxib in Head and Neck Cancer, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by Emory University · Phase 1, Interventional, and Prevention
This is a phase I study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).
This is a phase I study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).
The study will evaluate the effect on cells and clinical response to study medications: Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the medications will be assessed, and chemicals in the cells will be evaluated both before and after medication is administered that may show how the drugs work. This information will help researchers determine whether additional studies with these drugs should be conducted to determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.
SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new cases in the United States per year with 11,000 deaths. The five-year survival rate for patients with SCCHN in the United States and other developed countries is still poor, approximately 40%, comparable to the five-year survival rate in the 1970s despite advances in detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before the development of invasive cancer or second primary tumors (SPTs) is highly desirable and novel strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related malignancies are being pursued.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 10 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Erlotinib · Drug: Celecoxib
Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.
Also known as: OSI-774, Tarceva
Celecoxib, 400 mg, daily for 6 months.
Also known as: SC-58635, Celebrex
Define biologic dose of Erlotinib and Celecoxib in Erlotinib plus Celecoxib in patients with early stage (I/II) SCCHN. Improve overall survival rate by reducing SPTs and recurrence with combination of Erlotinib and Celecoxib.
Time frame: 6 months
Assess tolerability and toxicity associated with combination of Erlotinib and toxicity associated with combination of Erlotinib and Celecoxib for patients with early stage (I/II) SCCHN.
Time frame: 6 months
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University