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Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor

NCT00314262 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-10-24

Study results available
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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.

Conditions

  • Precancerous Conditions

Interventions

DRUG

Erlotinib & Celecoxib

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Dong Shin, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00314262 on ClinicalTrials.gov