Trial Outcomes & Findings for Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia (NCT NCT00081263)
NCT ID: NCT00081263
Last Updated: 2017-09-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Post treatment evaluation was done 14 to 18 weeks after treatment randomization
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
Arm I (Celecoxib)
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
63
|
|
Overall Study
COMPLETED
|
50
|
41
|
|
Overall Study
NOT COMPLETED
|
17
|
22
|
Reasons for withdrawal
| Measure |
Arm I (Celecoxib)
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
|---|---|---|
|
Overall Study
clerical error
|
1
|
0
|
|
Overall Study
wrong cell type
|
7
|
5
|
|
Overall Study
improper pre-protocol therapy
|
0
|
1
|
|
Overall Study
Inadequate pathology
|
0
|
1
|
|
Overall Study
Never treated
|
4
|
5
|
|
Overall Study
Inadequate data
|
5
|
10
|
Baseline Characteristics
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Baseline characteristics by cohort
| Measure |
Arm I (Celecoxib)
n=50 Participants
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
50 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
91 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Customized
18-19 years
|
1 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Age, Customized
20-29 years
|
30 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Age, Customized
30-39 years
|
13 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Age, Customized
40-49 years
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Cell Type
Cervical Intraepithelial Neoplasia 2/3
|
14 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Cell Type
Cervical Intraepithelial Neoplasia 3
|
36 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Post treatment evaluation was done 14 to 18 weeks after treatment randomizationPopulation: Eligible, Treated, and Evaluable patients
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.
Outcome measures
| Measure |
Arm I (Celecoxib)
n=50 Participants
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
|---|---|---|
|
Histologic Regression
|
40 percentage of participants
Interval 28.0 to 53.0
|
34.1 percentage of participants
Interval 22.0 to 48.0
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatmentPopulation: Eligible and treated patients.
Number of participants with a grade of 3 or higher during the treatment period.
Outcome measures
| Measure |
Arm I (Celecoxib)
n=50 Participants
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
|---|---|---|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Gastrointestinal
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pain
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksOutcome measures
Outcome data not reported
Adverse Events
Arm I (Celecoxib)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Celecoxib)
n=67 participants at risk
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=63 participants at risk
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
|---|---|---|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 ANC: Cervix
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • Number of events 1 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Other adverse events
| Measure |
Arm I (Celecoxib)
n=67 participants at risk
Patients receive oral celecoxib once daily for 14-18 weeks.
Celecoxib: Given orally
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=63 participants at risk
Patients receive oral placebo once daily for 14-18 weeks.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Constitutional Symptoms - Other
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Sweating
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Weight Gain
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fatigue
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.2%
2/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Insomnia
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
2/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.2%
2/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Heartburn
|
7.5%
5/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
3/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.2%
2/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
9.5%
6/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.3%
4/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.2%
2/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Dermal Change
|
3.0%
2/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
3/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Involuntary Movement
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
3/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Flashing Lights/Floaters
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Blurred Vision
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain - Other
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
1.5%
1/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Head/Headache
|
9.0%
6/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
15.9%
10/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Stomach
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Abdominal Pain Nos
|
6.0%
4/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
11.1%
7/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Muscle
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/67 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.6%
1/63 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place