Trial Outcomes & Findings for Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs) (NCT NCT00198081)
NCT ID: NCT00198081
Last Updated: 2016-02-29
Results Overview
Measured by Elisa at participant level - only participant level data available; not summarized across group
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline, surgery, 1 wk, 4 wks, and 6 months
Results posted on
2016-02-29
Participant Flow
Participant milestones
| Measure |
Surgical Candidate
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Medical Candidate
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
Baseline characteristics by cohort
| Measure |
Surgical Candidate
n=5 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Medical Candidate
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 participants
n=5 Participants
|
—
|
2 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
|
IPMN type
Adenoma
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
IPMN type
Low grade
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
IPMN type
Invasive
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
IPMN type
Not Otherwise Specified
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
IPMN type
Unknown
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, surgery, 1 wk, 4 wks, and 6 monthsMeasured by Elisa at participant level - only participant level data available; not summarized across group
Outcome measures
| Measure |
Surgical Candidate Baseline
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgery Candidate Surgery
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate One Week
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 4 Weeks
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 6 Months
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
|---|---|---|---|---|---|
|
Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Adenoma-Part 1
|
11800 pg/ml
|
13300 pg/ml
|
12100 pg/ml
|
19600 pg/ml
|
24000 pg/ml
|
|
Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN low-Part 2
|
21000 pg/ml
|
13400 pg/ml
|
4700 pg/ml
|
36300 pg/ml
|
16000 pg/ml
|
|
Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Invasive-Part 3
|
800 pg/ml
|
30000 pg/ml
|
15400 pg/ml
|
24800 pg/ml
|
3600 pg/ml
|
|
Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN NOS-Part 4
|
10100 pg/ml
|
8700 pg/ml
|
9500 pg/ml
|
40300 pg/ml
|
7500 pg/ml
|
PRIMARY outcome
Timeframe: Baseline, surgery, 1 wk, 4 wks, and 6 monthsMeasured by Elisa at participant level - only participant level data available; not summarized across group
Outcome measures
| Measure |
Surgical Candidate Baseline
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgery Candidate Surgery
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate One Week
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 4 Weeks
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 6 Months
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
|---|---|---|---|---|---|
|
Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Adenoma-Part 1
|
60 pg/ml
|
70 pg/ml
|
70 pg/ml
|
130 pg/ml
|
100 pg/ml
|
|
Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN low-Part 2
|
170 pg/ml
|
90 pg/ml
|
10 pg/ml
|
40 pg/ml
|
10 pg/ml
|
|
Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Invasive-Part 3
|
70 pg/ml
|
30 pg/ml
|
60 pg/ml
|
10 pg/ml
|
70 pg/ml
|
|
Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN NOS-Part 4
|
100 pg/ml
|
140 pg/ml
|
20 pg/ml
|
80 pg/ml
|
30 pg/ml
|
PRIMARY outcome
Timeframe: Baseline, surgery, 1 wk, 4 wks, and 6 monthsMeasured by Elisa at participant level - only participant level data available; not summarized across group
Outcome measures
| Measure |
Surgical Candidate Baseline
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgery Candidate Surgery
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate One Week
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 4 Weeks
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 6 Months
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
|---|---|---|---|---|---|
|
Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Adenoma-Part 1
|
196 pg/ml
|
177 pg/ml
|
354 pg/ml
|
431 pg/ml
|
522 pg/ml
|
|
Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN low-Part 2
|
257 pg/ml
|
201 pg/ml
|
153 pg/ml
|
594 pg/ml
|
366 pg/ml
|
|
Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Invasive-Part 3
|
128 pg/ml
|
NA pg/ml
Above the level of detection
|
850 pg/ml
|
453 pg/ml
|
184 pg/ml
|
|
Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN NOS-Part 4
|
131 pg/ml
|
100 pg/ml
|
184 pg/ml
|
417 pg/ml
|
88 pg/ml
|
PRIMARY outcome
Timeframe: Baseline, surgery, 1 wk, 4 wks, and 6 monthsMeasured by Elisa at participant level - only participant level data available; not summarized across group
Outcome measures
| Measure |
Surgical Candidate Baseline
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgery Candidate Surgery
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate One Week
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 4 Weeks
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Surgical Candidate 6 Months
n=4 Participants
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
|---|---|---|---|---|---|
|
Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Adenoma-Part 1
|
20 pg/ml
|
4 pg/ml
|
6.4 pg/ml
|
5.4 pg/ml
|
6.7 pg/ml
|
|
Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN low-Part 2
|
7 pg/ml
|
4.3 pg/ml
|
9.3 pg/ml
|
5.9 pg/ml
|
8.7 pg/ml
|
|
Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN Invasive-Part 3
|
2 pg/ml
|
3 pg/ml
|
11.8 pg/ml
|
5.1 pg/ml
|
8.3 pg/ml
|
|
Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
IPMN NOS-Part 4
|
9 pg/ml
|
3.4 pg/ml
|
7.2 pg/ml
|
4.3 pg/ml
|
1.8 pg/ml
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 1 yearPopulation: Data never collected for surgical arm; medical arm of study never initiated.
Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.
Outcome measures
Outcome data not reported
Adverse Events
Surgical Candidate
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Medical Candidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Surgical Candidate
n=5 participants at risk
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Medical Candidate
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP
|
|---|---|---|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, [NEUROLEPTIC REACTION]
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, [CONGESTIVE HEART FAILURE]
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
Other adverse events
| Measure |
Surgical Candidate
n=5 participants at risk
COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery
|
Medical Candidate
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP
|
|---|---|---|
|
Cardiac disorders
EKG CHANGES
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Cardiac disorders
PALPITATIONS
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Cardiac disorders
ARRTHYTHMIA
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
DIARRHEA
|
40.0%
2/5 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
PANCREATIC FISTULA
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
PAIN
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
General disorders
FATIGUE
|
40.0%
2/5 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
|
General disorders
EDEMA: LIMB SWELLING OF THE ARMS AND/OR LEGS
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
General disorders
FLU-TYPE SYMPTOMS (INCLUDING BODY ACHES, FEVER, CHILLS, TIREDNESS,LOSS OF APPETITE, COUGH)
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Infections and infestations
TOOTH INFECTION
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Injury, poisoning and procedural complications
SEROMA
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Investigations
INR INCREASED
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Investigations
PLATELET COUNT DECREASED
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
40.0%
2/5 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, [RUNNY NOSE]
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
|
Vascular disorders
HYPOTENSION
|
20.0%
1/5 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place