- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072540
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
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.
Study Overview
Status
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: William R. Robinson, MD, Harrington Cancer Center
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Neoplasms, Squamous Cell
- Uterine Cervical Dysplasia
- Carcinoma in Situ
- Carcinoma, Squamous Cell
- Squamous Intraepithelial Lesions of the Cervix
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Mitosis Modulators
- Cyclooxygenase 2 Inhibitors
- Celecoxib
- Enzyme Inhibitors
- Mitogens
Other Study ID Numbers
- CDR0000340176
- U10CA037429 (U.S. NIH Grant/Contract)
- S0212 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage 0 Cervical Cancer
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedLymphedema | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Stage III Vulvar Cancer | Stage IVB Vulvar Cancer | Stage 0 Cervical Cancer | Stage 0 Vulvar Cancer | Stage I Vulvar Cancer | Stage IA Cervical Cancer | Stage IB Cervical... and other conditionsUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)WithdrawnCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2 | Cervical Intraepithelial Neoplasia Grade 3 | Stage III Vulvar Cancer | Recurrent Cervical Cancer | Recurrent Vaginal Cancer | Recurrent Vulvar Cancer | Stage 0 Cervical Cancer | Stage 0 Vaginal Cancer | Stage 0 Vulvar... and other conditions
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Carcinoma | Cervical Intraepithelial Neoplasia Grade 2/3 | Stage 0 Cervical CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedPrecancerous Condition | Stage 0 Cervical CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Prognostic Stage I Breast Cancer AJCC v8 | Prognostic Stage IA Breast Cancer AJCC v8 | Prognostic Stage IB Breast Cancer AJCC v8 | Anatomic Stage 0 Breast Cancer AJCC v8 | Prognostic...United States
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Recurrent Vaginal Cancer | Stage IB Cervical Cancer | Stage II Vaginal Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage III Vaginal Cancer | Stage IVA Cervical Cancer | Stage IVA Vaginal Cancer | Stage IVB Cervical Cancer | Stage IVB... and other conditionsUnited States
Clinical Trials on celecoxib
-
Chong Kun Dang PharmaceuticalCompletedOsteoarthritis HandKorea, Republic of
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHealthy VolunteersSingapore
-
Yooyoung Pharmaceutical Co., Ltd.CliPS Co., LtdCompletedOsteoarthritis, KneeKorea, Republic of
-
Yooyoung Pharmaceutical Co., Ltd.CliPSBnCRecruitingOsteoarthritis, KneeKorea, Republic of
-
Samsung Medical CenterThe Korean Urological AssociationWithdrawnBenign Prostatic HyperplasiaKorea, Republic of
-
Seoul National University HospitalCompletedIntracerebral HemorrhageKorea, Republic of
-
Dr. Reddy's Laboratories LimitedCompleted
-
Amsterdam UMC, location VUmcNetherlands Brain FoundationRecruitingInflammation | Depressive Disorder, MajorNetherlands
-
Targeted Therapy Technologies, LLCRecruitingMacula Edema | Epiretinal Membrane | Branch Retinal Vein Occlusion | Radiation Retinopathy | Central Serous Retinopathy With Pit of Optic Disc | Commotio Retinae | VitritisUnited States
-
Xintian PharmaceuticalNot yet recruiting