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

Stage 0 Cervical Cancer Clinical Trial

Official title:

S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00072540
• Other study ID #: CDR0000340176
• Secondary ID: S0212U10CA037429
• Status: Withdrawn
• Phase: Phase 2
• First received: November 4, 2003
• Last updated: November 7, 2013

Study information

• Verified date: November 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• High-grade Squamous Intraepithelial Lesion
• Stage 0 Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• celecoxib

Procedure:
• anti-cytokine therapy

• antiangiogenesis therapy

• biological therapy

• cancer prevention intervention

• chemoprevention of cancer

• enzyme inhibitor therapy

• growth factor antagonist therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)