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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052611
First received: January 24, 2003
Last updated: July 23, 2008
Last verified: January 2005

January 24, 2003
July 23, 2008
June 2002
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Complete list of historical versions of study NCT00052611 on ClinicalTrials.gov Archive Site
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Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia
Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Prevention
Head and Neck Cancer
Drug: celecoxib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • Oral leukoplakia on clinical examination AND/OR
  • More than one prior squamous cell carcinoma (SCC) of the head and neck and dysplasia on biopsy within the past 6 months
  • Carcinoma in situ or new leukoplakia eligible provided treatment for a prior carcinoma was completed more than 9 months ago

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 months

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Transaminases less than 1.5 times ULN
  • PT/PTT less than 1.5 times ULN
  • No acute or chronic liver disease

Renal

  • Creatinine less than 1.5 times ULN
  • Urine protein less than 2+
  • No acute or chronic renal insufficiency

Cardiovascular

  • No New York Heart Association class II congestive heart failure
  • No prior myocardial infarction
  • No angina
  • No known coronary artery disease

Pulmonary

  • No advanced chronic obstructive pulmonary disease requiring home oxygen use

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection within the past 2 weeks
  • No concurrent infection
  • No concurrent tobacco use (e.g., cigarette, cigar, pipe, or chewing tobacco)

    • At least 1 month since prior use
  • No active alcohol abuse
  • No history of gastrointestinal ulcer
  • No history of anaphylactoid reaction to aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
  • No concurrent active malignancy except non-melanoma skin cancer
  • No contraindication to nasopharyngoscopy and biopsy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • More than 3 months since prior absorbed steroids, including inhaled and nasal steroids (3 times a week for at least 2 consecutive weeks)

    • Prior mometasone allowed

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Prior surgery for SCC of the head and neck allowed provided patient has been cancer free for at least 9 months

Other

  • More than 3 months since prior full-dose aspirin, COX-2 inhibitors, or NSAIDs (at least 3 times a week for at least 2 weeks)
  • More than 3 months since prior retinoids or selenium
  • No concurrent lithium or fluconazole
  • No concurrent diuretics for congestive heart failure
  • No concurrent angiotensin-converting enzyme inhibitors
  • Concurrent aspirin allowed if dosage no greater than 81 mg per day
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00052611
CDR0000258562, DFCI-02024, DFCI-2002-P-00150/2
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Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Lori J. Wirth, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP