ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

Celecoxib and/or EKB-569 in Preventing Oral Cancer in Patients With Oral Leukoplakia

This study is not yet open for patient recruitment.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib and/or EKB-569 may be effective in preventing the development of oral cancer in patients who have oral leukoplakia.

PURPOSE: Randomized clinical trial to study the effectiveness of celecoxib and/or EKB-569 in preventing oral cancer in patients who have oral leukoplakia.

Condition Treatment or Intervention
lip and oral cavity cancer
Salivary Gland Cancer
Precancerous Condition
 Drug: EKB-569
 Drug: celecoxib
 Procedure: biological response modifier therapy
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: enzyme inhibitor therapy
 Procedure: prostaglandin inhibition
 Procedure: protein tyrosine kinase inhibitor therapy

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Oral Cancer;   Salivary Gland Disorders

Study Type: Interventional
Study Design: Prevention

Official Title: Randomized Study of Celecoxib and EKB-569, as Monotherapy or in Combination, For Prevention of Oral Cancer in Patients With Aneuploid Oral Leukoplakia

Further Study Details: 

OBJECTIVES: Primary

Secondary

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to Nordic country of participation and cardioprotective acetylsalicylic acid use (yes vs no). Patients are randomized to 1 of 4 treatment arms.

Patients are followed at every 3 months for 2 years and then every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 360 patients (90 per treatment arm) will be accrued for this study within 2-3 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Pulmonary

Gastrointestinal

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location Information


Study chairs or principal investigators

Scott Michael Lippman, MD, FACP,  Principal Investigator,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000377364; MDA-2003-0824; MDA-NRH-2003-16
Record last reviewed:  September 2004
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00088842
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act