We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081263
Recruitment Status : Completed
First Posted : April 8, 2004
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Tracking Information
First Submitted Date  ICMJE April 7, 2004
First Posted Date  ICMJE April 8, 2004
Results First Submitted Date  ICMJE November 29, 2016
Results First Posted Date  ICMJE September 15, 2017
Last Update Posted Date September 15, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 13, 2017)
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Carcinoma
  • Cervical Intraepithelial Neoplasia Grade 2/3
  • Stage 0 Cervical Cancer
Intervention  ICMJE
  • Drug: Celecoxib
    Given orally
    Other Names:
    • Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
    • Celebrex
    • SC-58635
    • YM 177
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Placebo
    Given orally
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
Study Arms  ICMJE
  • Experimental: Arm I (celecoxib)
    Patients receive oral celecoxib once daily for 14-18 weeks.
    Interventions:
    • Drug: Celecoxib
    • Other: Laboratory Biomarker Analysis
  • Placebo Comparator: Arm II (placebo)
    Patients receive oral placebo once daily for 14-18 weeks.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Other: Placebo
Publications * Rader JS, Sill MW, Beumer JH, Lankes HA, Benbrook DM, Garcia F, Trimble C, Tate Thigpen J, Lieberman R, Zuna RE, Leath CA 3rd, Spirtos NM, Byron J, Thaker PH, Lele S, Alberts D. A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017 May;145(2):291-297. doi: 10.1016/j.ygyno.2017.02.040. Epub 2017 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2010)
130
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy between 2 and 8 weeks prior to enrollment

    • For a patient to be eligible, the pathology report must clearly state "CIN 2/3" or "CIN 3" or must state "moderate-severe dysplasia", "moderate-severe dyskaryosis," "severe dysplasia," or "severe dyskaryosis;" patients with a diagnosis of CIN 2 alone or moderate dysplasia or dyskaryosis alone are not eligible for this study (3/26/2007)
  • Patients must have a satisfactory (readable, good quality) colposcopic evaluation at least 14 days after diagnostic biopsy
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must have colposcopically visible cervical lesion at entry consistent with biopsy
  • Patients must have a negative urine pregnancy test; women of childbearing potential must practice an acceptable form of contraception (e.g. intrauterine device, contraceptive pills, diaphragm, condoms)
  • Patients must have a GOG Performance Status of 0, 1, or 2
  • Patients must agree to refrain from using non-steroidal anti-inflammatory drugs (NSAIDS) and aspirin during the time they are taking the study medication
  • Patients must be good candidates for delayed treatment of their CIN, i.e. they must be reliable to return for follow-up and provide a combination of at least three phone numbers or addresses for contact
  • Hemoglobin (HgB) greater than 11.0g/dl
  • White blood cell (WBC) count greater than 3000/mcl
  • Platelet count greater than 125,000/mcl (3/26/2007)
  • Creatinine less than or equal to 1.5 x upper limit normal (ULN)
  • Total bilirubin less than or equal to 1.5 x ULN excluding Gilbert's disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.0 x ULN

Exclusion Criteria:

  • Patients who are pregnant or lactating
  • Patients with cytologic or biopsy evidence of endocervical dysplasia or invasive cancer
  • Patients with undiagnosed abnormal vaginal bleeding
  • Patients who have previously taken celecoxib or any other COX-2 inhibitor at a frequency of greater than 3 times per week within 2 months (60 days) prior to randomization; patients can use Naproxen without restriction (6/23/2008)
  • Patients with a known immunocompromised condition
  • Patients who have had a known allergic reaction to any NSAIDS or aspirin (asthma, urticaria, allergic-type reaction)
  • Patients with a prior history of cervical cancer
  • Patients with hypersensitivity to Celecoxib
  • Patients with a known allergic reaction to sulfonamides
  • Patients with a history of peptic ulcer disease
  • Patients currently using fluconazole or lithium
  • Patients with a chronic or acute renal, or hepatic disorder, a significant bleeding disorder, or any other condition which in the investigator's opinion might preclude study participation for the duration of the trial
  • Patients with a history of transient ischemic attack (TIA), stroke, cardiovascular disease or uncontrolled hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   Canada,   Japan,   Norway,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00081263
Other Study ID Numbers  ICMJE GOG-0207
NCI-2009-00583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000360805
GOG-0207 ( Other Identifier: NRG Oncology )
GOG-0207 ( Other Identifier: DCP )
GOG-0207 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party GOG Foundation ( Gynecologic Oncology Group )
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Gynecologic Oncology Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Janet Rader NRG Oncology
PRS Account GOG Foundation
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP