This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.
Full Title of Study: “A Randomized Double-Blind Phase II Trial of Celecoxib, A COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or 3)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: September 2012
PRIMARY OBJECTIVES: I. To determine the efficacy of celecoxib to induce complete remission (or partial regression to cervical intraepithelial neoplasia (CIN) 1) of CIN 2/3 or CIN 3 as evaluated in the post-treatment excisional biopsy. II. To determine the toxicity of celecoxib (400 mg once daily) as assessed by Common Terminology Criteria for Adverse Events in this patient population of women with CIN 2/3 or CIN 3. SECONDARY OBJECTIVES: I. To assess whether treatment with celecoxib changes the number of quadrants containing acetowhite lesions as determined through colposcopic examination. II. To determine the efficacy of celecoxib treatment in changing human papillomavirus (HPV) viral load in cervical cells. III. To examine the association of histologic response; HPV viral load; lesion size; proliferation index (marker of proliferation Ki-67 [Ki67]), apoptosis index (terminal deoxynucleotidyl transferase (TdT)-mediated dUTP nick end labelin [TUNEL] assay), angiogenesis (vascular endothelial growth factor [VEGF]), and cyclooxygenase-2 (COX-2) in tissue; the amount of VEGF and basic fibroblast growth factor (bFGF) in serum before and after treatment; and the amount of celecoxib present in serum during treatment. Cervical cytology karyometry will be assessed as a potential marker for regression IV. To determine the feasibility of digital imaging, web-based review of histopathology in a Gynecologic Oncology Group (GOG) study. V. To compare the diagnoses of the web-based review of histopathology with the diagnoses of GOG's standard procedure. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral celecoxib once daily for 14-18 weeks. ARM II: Patients receive oral placebo once daily for 14-18 weeks.
- Drug: Celecoxib
- Given orally
- Other: Laboratory Biomarker Analysis
- Correlative studies
- Other: Placebo
- Given orally
Arms, Groups and Cohorts
- Experimental: Arm I (celecoxib)
- Patients receive oral celecoxib once daily for 14-18 weeks.
- Placebo Comparator: Arm II (placebo)
- Patients receive oral placebo once daily for 14-18 weeks.
Clinical Trial Outcome Measures
- Histologic Regression
- Time Frame: Post treatment evaluation was done 14 to 18 weeks after treatment randomization
- Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.
- Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
- Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
- Number of participants with a grade of 3 or higher during the treatment period.
Participating in This Clinical Trial
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Janet Rader, Principal Investigator, NRG Oncology
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