Clinical Trial: Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.


Detailed Summary:

OBJECTIVES:

  • Determine the response rate, in terms of prostaglandin E2 expression, in patients with oral leukoplakia and/or dysplasia treated with celecoxib.
  • Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF, and CD31, in patients treated with this drug.
  • Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia lesions and presence of dysplasia, in these patients.
  • Correlate change in biomarker expression with response of oral leukoplakia lesions and/or dysplasia in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a repeat biopsy. Patients with a positive response receive celecoxib for an additional 9 months.

Patients are followed every 3-6 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 24, 2003
Date Started: June 2002
Date Completion:
Last Updated: July 23, 2008
Last Verified: January 2005