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

NCT00400374 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-03-15

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Erlotinib

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

DRUG

Celecoxib

Celecoxib, 400 mg, daily for 6 months.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • National Cancer Institute (NCI)

    collaborator NIH
  • Emory University

    lead OTHER

Principal Investigators

  • Dong Shin, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2012-12-31
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

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 NCT00400374 on ClinicalTrials.gov