At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
Erlotinib & Celecoxibdrug
Likely dose
Erlotinib & Celecoxib 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Erlotinib & Celecoxib for Precancerous Conditions. Completed, enrolled 17 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrecancerous Conditions
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2006
Enrollment StartOct 2006
Primary CompletionNov 2012
TodayJul 2026
First PostedApr 13, 2006
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.2 years ago
Interventions
Erlotinib & Celecoxibdrug
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.