Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT00400374
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.
  • Celecoxib — DRUG
    Celecoxib, 400 mg, daily for 6 months.

Study Details

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).

Key Dates

First listed
Nov 16, 2006
Start date
Aug 31, 2007
Status verified
Mar 2018
Primary completion
Dec 31, 2012
Completion
Nov 30, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Erlotinib, Celecoxib

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Emory University Winship Cancer Institute· Atlanta, GA

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