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

SWOG Cancer Research Network

Status and phase

Withdrawn

Phase 2

Conditions

Stage 0 Cervical Cancer

High-grade Squamous Intraepithelial Lesion

Treatments

Procedure: growth factor antagonist therapy

Procedure: biological therapy

Procedure: chemoprevention of cancer

Procedure: enzyme inhibitor therapy

Procedure: antiangiogenesis therapy

Procedure: cancer prevention intervention

Drug: celecoxib

Procedure: anti-cytokine therapy

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00072540

CDR0000340176

U10CA037429 (U.S. NIH Grant/Contract)

S0212 (Other Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo.
Compare the toxicity of these drugs in these patients.
Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-grade squamous intraepithelial lesion status (cervical intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral celecoxib twice daily for 1 month.
Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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