A Randomized Double-Blind Phase II Trial of Celecoxib, a COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or CIN 3)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 by
cervical biopsy 2-8 weeks prior to study entry

- Pathology report must clearly state "CIN 2/3" or "3" OR "moderate-severe
dysplasia," "moderate-severe dyskaryosis," "severe dysplasia," or "sever
dyskaryosis."

- No CIN 2 alone OR moderate dysplasia or dyskaryosis alone

- 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

- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Platelet count > 125,000/mm^3

- Hemoglobin > 11.0 g/dL

- WBC > 3,000/mm^3

- No significant bleeding disorder

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (> 1.5 times ULN allowed if due to
Gilbert's disease)

- AST and ALT < 2.0 times ULN

- No hepatic disorder

Renal

- Creatinine ≤ 1.5 times ULN

- No known renal failure

Cardiovascular

- No history of transient ischemic attack or stroke

- No history of cardiovascular disease

- No uncontrolled hypertension

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

- No history of peptic ulcer disease

- 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

- No concurrent fluconazole or lithium