Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
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|ClinicalTrials.gov Identifier: NCT00081263|
Recruitment Status : Completed
First Posted : April 8, 2004
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Carcinoma Cervical Intraepithelial Neoplasia Grade 2/3 Stage 0 Cervical Cancer||Drug: Celecoxib Other: Laboratory Biomarker Analysis Other: Placebo||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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 Start Date :||June 2005|
|Actual Primary Completion Date :||September 2012|
Experimental: Arm I (celecoxib)
Patients receive oral celecoxib once daily for 14-18 weeks.
Other: Laboratory Biomarker Analysis
Placebo Comparator: Arm II (placebo)
Patients receive oral placebo once daily for 14-18 weeks.
Other: Laboratory Biomarker Analysis
- 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.
- To Examine the Association of Histologic Response in COX-2 in Tissue [ Time Frame: Up to 18 weeks ]
- To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment [ Time Frame: Up to 18 weeks ]
- HPV Viral Load Before and After Treatment [ Time Frame: Up to 18 weeks ]
- To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment. [ Time Frame: Up to 18 weeks ]
- Levels of Serum bFGF [ Time Frame: Up to 18 weeks ]
- Levels of Serum VEGF [ Time Frame: Up to 18 weeks ]
- To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method). [ Time Frame: Baseline ]
- To Examine the Association of Histologic Response in Proliferation Index (Ki67). [ Time Frame: Up to 18 weeks ]
- Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review [ Time Frame: Baseline ]
- The Number of Quadrants Involving CIN [ Time Frame: Up to 18 weeks ]
- To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay) [ Time Frame: Up to 18 weeks ]
- To Examine the Association of Histologic Response in Angiogenisis (VEGF) [ Time Frame: Up to 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081263
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|Principal Investigator:||Janet Rader||NRG Oncology|