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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Cervical Carcinoma
Cervical Intraepithelial Neoplasia Grade 2/3
Stage 0 Cervical Cancer
Interventions Drug: Celecoxib
Other: Laboratory Biomarker Analysis
Other: Placebo
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Celecoxib) Arm II (Placebo)
Hide Arm/Group Description

Patients receive oral celecoxib once daily for 14-18 weeks.

Celecoxib: Given orally

Laboratory Biomarker Analysis: Correlative studies

Patients receive oral placebo once daily for 14-18 weeks.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given orally
Period Title: Overall Study
Started 67 63
Completed 50 41
Not Completed 17 22
Reason Not Completed
clerical error             1             0
wrong cell type             7             5
improper pre-protocol therapy             0             1
Inadequate pathology             0             1
Never treated             4             5
Inadequate data             5             10
Arm/Group Title Arm I (Celecoxib) Arm II (Placebo) Total
Hide Arm/Group Description

Patients receive oral celecoxib once daily for 14-18 weeks.

Celecoxib: Given orally

Laboratory Biomarker Analysis: Correlative studies

Patients receive oral placebo once daily for 14-18 weeks.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given orally

 Total of all reporting groups
Overall Number of Baseline Participants 50 41 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 50 participants 41 participants 91 participants
18-19 years
1
   2.0%
5
  12.2%
6
   6.6%
20-29 years
30
  60.0%
23
  56.1%
53
  58.2%
30-39 years
13
  26.0%
10
  24.4%
23
  25.3%
40-49 years
6
  12.0%
3
   7.3%
9
   9.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 41 participants 91 participants
Female
50
 100.0%
41
 100.0%
91
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Cell Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 50 participants 41 participants 91 participants
Cervical Intraepithelial Neoplasia 2/3
14
  28.0%
11
  26.8%
25
  27.5%
Cervical Intraepithelial Neoplasia 3
36
  72.0%
30
  73.2%
66
  72.5%
[1]
Measure Description:

Cell Type Definitions:

Cervical Intraepithelial Neoplasia 2/3 is defined as moderate-severe dysplasia or moderate-severe dyskaryosis.

Cervical Intraepithelial Neoplasia 3 is defined as severe dysplasia or severe dyskaryosis.
1.Primary Outcome
Title Histologic Regression
Hide Description 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.
Time Frame Post treatment evaluation was done 14 to 18 weeks after treatment randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, Treated, and Evaluable patients
Arm/Group Title Arm I (Celecoxib) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive oral celecoxib once daily for 14-18 weeks.

Celecoxib: Given orally

Laboratory Biomarker Analysis: Correlative studies

Patients receive oral placebo once daily for 14-18 weeks.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given orally
Overall Number of Participants Analyzed 50 41
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
40
(28 to 53)
34.1
(22 to 48)
2.Primary Outcome
Title Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hide Description Number of participants with a grade of 3 or higher during the treatment period.
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Arm I (Celecoxib) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive oral celecoxib once daily for 14-18 weeks.

Celecoxib: Given orally

Laboratory Biomarker Analysis: Correlative studies

Patients receive oral placebo once daily for 14-18 weeks.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given orally
Overall Number of Participants Analyzed 50 41
Measure Type: Number
Unit of Measure: participants
Gastrointestinal 1 0
Pain 0 1
3.Other Pre-specified Outcome
Title To Examine the Association of Histologic Response in COX-2 in Tissue
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title HPV Viral Load Before and After Treatment
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment.
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Levels of Serum bFGF
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Levels of Serum VEGF
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method).
Hide Description [Not Specified]
Time Frame Baseline
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title To Examine the Association of Histologic Response in Proliferation Index (Ki67).
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review
Hide Description [Not Specified]
Time Frame Baseline
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title The Number of Quadrants Involving CIN
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay)
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title To Examine the Association of Histologic Response in Angiogenisis (VEGF)
Hide Description [Not Specified]
Time Frame Up to 18 weeks
Outcome Measure Data Not Reported
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Celecoxib) Arm II (Placebo)
Hide Arm/Group Description

Patients receive oral celecoxib once daily for 14-18 weeks.

Celecoxib: Given orally

Laboratory Biomarker Analysis: Correlative studies

Patients receive oral placebo once daily for 14-18 weeks.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given orally
All-Cause Mortality
Arm I (Celecoxib) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm I (Celecoxib) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      1/63 (1.59%)    
Infections and infestations     
Inf W/Nml Or Gr 1 Or 2 ANC: Cervix * 1  0/67 (0.00%)  0 1/63 (1.59%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 3.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Celecoxib) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/67 (37.31%)      25/63 (39.68%)    
Blood and lymphatic system disorders     
Hemoglobin * 1  1/67 (1.49%)  0/63 (0.00%) 
Edema: Limb * 1  1/67 (1.49%)  0/63 (0.00%) 
Dermal Change * 1  2/67 (2.99%)  3/63 (4.76%) 
Eye disorders     
Flashing Lights/Floaters * 1  0/67 (0.00%)  1/63 (1.59%) 
Blurred Vision * 1  1/67 (1.49%)  0/63 (0.00%) 
Gastrointestinal disorders     
Flatulence * 1  2/67 (2.99%)  2/63 (3.17%) 
Heartburn * 1  5/67 (7.46%)  3/63 (4.76%) 
Ulcer,gi - Stomach * 1  1/67 (1.49%)  0/63 (0.00%) 
Vomiting * 1  1/67 (1.49%)  2/63 (3.17%) 
Constipation * 1  0/67 (0.00%)  1/63 (1.59%) 
Nausea * 1  3/67 (4.48%)  6/63 (9.52%) 
Gastrointestinal - Other * 1  0/67 (0.00%)  1/63 (1.59%) 
Diarrhea * 1  1/67 (1.49%)  4/63 (6.35%) 
General disorders     
Constitutional Symptoms - Other * 1  0/67 (0.00%)  1/63 (1.59%) 
Sweating * 1  0/67 (0.00%)  1/63 (1.59%) 
Weight Gain * 1  1/67 (1.49%)  1/63 (1.59%) 
Fatigue * 1  1/67 (1.49%)  2/63 (3.17%) 
Insomnia * 1  0/67 (0.00%)  1/63 (1.59%) 
Pain - Other * 1  1/67 (1.49%)  0/63 (0.00%) 
Pain: Throat/Pharynx/Larynx * 1  1/67 (1.49%)  0/63 (0.00%) 
Pain: Head/Headache * 1  6/67 (8.96%)  10/63 (15.87%) 
Pain: Stomach * 1  0/67 (0.00%)  1/63 (1.59%) 
Pain: Abdominal Pain Nos * 1  4/67 (5.97%)  7/63 (11.11%) 
Pain: Muscle * 1  0/67 (0.00%)  1/63 (1.59%) 
Infections and infestations     
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  1/67 (1.49%)  0/63 (0.00%) 
Inf Unknown Anc: Sinus * 1  0/67 (0.00%)  1/63 (1.59%) 
Nervous system disorders     
Involuntary Movement * 1  0/67 (0.00%)  1/63 (1.59%) 
Somnolence * 1  0/67 (0.00%)  1/63 (1.59%) 
Dizziness * 1  0/67 (0.00%)  3/63 (4.76%) 
Renal and urinary disorders     
Incontinence, Urinary * 1  0/67 (0.00%)  1/63 (1.59%) 
Reproductive system and breast disorders     
Vaginal Discharge * 1  0/67 (0.00%)  1/63 (1.59%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/67 (0.00%)  1/63 (1.59%) 
Pruritus * 1  0/67 (0.00%)  1/63 (1.59%) 
Vascular disorders     
Hemorrhage, Gu - Vagina * 1  1/67 (1.49%)  2/63 (3.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier: NCT00081263    
Other Study ID Numbers: 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 )
First Submitted: April 7, 2004
First Posted: April 8, 2004
Results First Submitted: November 29, 2016
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017