S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing cervical cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib; Enzyme Inhibitors; Mitogens

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the cervix

• Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe dysplasia, carcinoma in situ)

• Must have remaining HGSIL after biopsy

• No suspicion of invasive cancer by colposcopy within the past 28 days

• No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• SGOT and SGPT less than 2.0 times upper limit of normal (ULN)

• Bilirubin less than 2.0 times ULN

Renal

• Creatinine less than 2.0 mg/dL

Immunologic

• No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs

• No allergy to sulfonamides

• No known sensitivity to celecoxib

• No known AIDS or HIV-associated complex

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 3 months since prior topical medications for genital condyloma

• No prior treatment for squamous intraepithelial lesions

• No concurrent topical medications for genital condyloma

• No other concurrent treatment

• No concurrent chronic (daily for more than 30 days) aspirin

• No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)