Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072540

Purpose

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.

Condition	Intervention	Phase
Stage 0 Cervical Cancer High-Grade Squamous Intraepithelial Lesion	Drug: celecoxib Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological therapy Procedure: cancer prevention intervention Procedure: chemoprevention of cancer Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072540

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Charles A. Coltman, MD	San Antonio Cancer Institute
Investigator:	David S. Alberts, MD	University of Arizona
Investigator:	William R. Robinson, MD	Harrington Cancer Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00072540 History of Changes
Other Study ID Numbers:	CDR0000340176, SWOG-S0212
Study First Received:	November 4, 2003
Last Updated:	June 14, 2006
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Enzyme Inhibitors
Celecoxib
Mitogens
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Mitosis Modulators
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012