RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

Condition	Treatment or Intervention	Phase
Cervical Cancer high-grade squamous intraepithelial lesion	Drug: celecoxib  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: enzyme inhibitor therapy  Procedure: growth factor antagonist therapy	Phase II

OBJECTIVES: Primary

• Determine the efficacy of celecoxib, in terms of achieving histologic complete or partial response, in patients with cervical intraepithelial neoplasia 3.
• Determine the toxicity of this drug in these patients.

Secondary

• Determine the effect of this drug on changes in lesion size in these patients.
• Determine the effect of this drug on human papillomavirus (HPV) viral load in these patients.
• Correlate histologic response, HPV viral load, lesion size, proliferation index, apoptosis index, angiogenesis (VEGF) and COX-2 in tissue, amount of VEGF and bFGF in serum, and serum celecoxib levels during treatment in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral celecoxib twice daily.
• Arm II: Patients receive oral placebo twice daily. Treatment on both arms continues in the absence of disease progression or unacceptable toxicity.

Patients undergo colposcopy at week 8 and between weeks 14 and 18. Between weeks 14 and 18, patients also undergo large loop excision of the transformation zone or cone biopsy.

PROJECTED ACCRUAL: A maximum of 100 patients (50 per treatment arm) will be accrued for this study within 13 months.

Ages Eligible for Study:  17 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cervical intraepithelial neoplasia 3 (CIN 3) by cervical biopsy 2-8 weeks prior to study entry
• Colposcopically visible cervical lesion at study entry that is consistent with biopsy
• No evidence of endocervical dysplasia or invasive cancer by cytology or biopsy
• No history of cervical cancer

PATIENT CHARACTERISTICS: Age

• 17 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• No known renal failure

Other

• No undiagnosed abnormal vaginal bleeding
• No known immunocompromised condition
• No known allergic reaction (such as asthma, urticaria, or other reaction) to NSAIDs or aspirin
• No known hypersensitivity to celecoxib
• No known allergic reaction to sulfonamides
• Must be good candidate for delayed treatment of CIN (i.e., deemed reliable to return for follow-up and provide adequate contact information)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• No prior renal transplantation

Other

• At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or aspirin
• No other concurrent NSAIDs or aspirin

Study chairs or principal investigators

Janet Sue Rader, MD,  Study Chair,  Washington University Siteman Cancer Center   
Carolyn Y. Muller, MD,  Simmons Cancer Center   

Study ID Numbers:  CDR0000360805; GOG-0207
Record last reviewed:  March 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00081263
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20