Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Closed	18 and over	NCI	DFCI-02024 DFCI-2002-P-00150/2, NCT00052611

Objectives

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

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 months

Hematopoietic

• Platelet count at least 100,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Lori Wirth, MD, Protocol chair		Ph: 617-632-3090; 866-790-4500 Email: lori_wirth@dfci.harvard.edu

Registry Information
Official Title		Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study
Trial Start Date		2002-06-21
Registered in ClinicalTrials.gov		NCT00052611
Date Submitted to PDQ		2002-10-11
Information Last Verified		2005-01-28
NCI Grant/Contract Number		P30-CA06516

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