Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT00314262
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Precancerous Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib & Celecoxib — DRUGErlotinib 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.
Study Details
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.
Key Dates
- First listed
- Apr 13, 2006
- Start date
- Oct 31, 2006
- Status verified
- Oct 2014
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
Study Design
- Enrollment
- 17 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Erlotinib & Celecoxib
Primary Outcome Measure
Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4 [ Time Frame: 12 months from time of enrollment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | - |
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