A Phase 2 interventional study of COX-2 Inhibitor 6-8 weeks prior to surgery and COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP in Pancreas Neoplasms, sponsored by Indiana University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by Indiana University School of Medicine · Phase 2, Interventional, and Prevention
The purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.
Efforts at finding a successful chemotherapy for pancreatic cancer have been disappointing. Some patients are at increased risk of pancreatic cancer or may have pre-malignant pancreatic lesions which predispose them to later pancreatic cancer development. In these individuals, chemopreventative measures may block future development of pancreatic cancer. Human tissue studies, cell culture and animal models of pancreatic cancer strongly suggests that cyclooxygenase-2 (COX-2) may be a successful target for chemoprevention. COX-2 is overexpressed in human pancreatic cancers. Elevated COX-2 expression correlates with progression of premalignant precursors of pancreatic cancer in development models of hamster pancreatic cancer. Human tissue studies confirm increases in COX-2 expression with progression of premalignant precursors called intraductal papillary mucinous neoplasms (IPMNs) and pancreatic intraepithelial neoplasms (PanINs). Moreover, COX-2 inhibitors appear to have chemopreventative efficacy in the PC-1 homograft model of hamster pancreatic cancer. Demographic studies have suggested COX-2 inhibitors may confer protection from pancreatic cancer. We propose to conduct a pilot/phase II trial to determine the chemopreventative effects of the COX-2 inhibitor celecoxib in patients with premalignant pancreatic lesions.
Patients registered to the study will take celecoxib twice daily for 6-8 weeks prior to surgery (if patient decides to have surgery for his/her condition). If subject is not a surgical candidate or puts off surgical treatment, subject will take celecoxib for 6 months.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
COX-2 Inhibitor 6-8 weeks prior to surgery
Drug: COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
400 mg BID 6-8 weeks prior to surgery
Also known as: Celecoxib
400 mg BID for 6 months prior to follow-up EUS or ERCP
Also known as: Celecoxib
Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
Measured by Elisa at participant level - only participant level data available; not summarized across group
Time frame: Baseline, surgery, 1 wk, 4 wks, and 6 months
Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
Measured by Elisa at participant level - only participant level data available; not summarized across group
Time frame: Baseline, surgery, 1 wk, 4 wks, and 6 months
Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
Measured by Elisa at participant level - only participant level data available; not summarized across group
Time frame: Baseline, surgery, 1 wk, 4 wks, and 6 months
Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
Measured by Elisa at participant level - only participant level data available; not summarized across group
Time frame: Baseline, surgery, 1 wk, 4 wks, and 6 months
Number of Participants With Clinical Changes in IPMN Progression.
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.
Time frame: Baseline, 6 months, 1 year
| Milestone | Surgical Candidate | Medical Candidate |
|---|---|---|
| Started | 5 | 0 |
| Completed | 4 | 0 |
| Not completed | 1 | 0 |
Measured by Elisa at participant level - only participant level data available; not summarized across group
| pg/ml | Surgical Candidate Baseline | Surgery Candidate Surgery | Surgical Candidate One Week | Surgical Candidate 4 Weeks | Surgical Candidate 6 Months |
|---|---|---|---|---|---|
| IPMN Adenoma-Part 1 | 11800 | 13300 | 12100 | 19600 | 24000 |
| IPMN low-Part 2 | 21000 | 13400 | 4700 | 36300 | 16000 |
| IPMN Invasive-Part 3 | 800 | 30000 | 15400 | 24800 | 3600 |
| IPMN NOS-Part 4 | 10100 | 8700 | 9500 | 40300 | 7500 |
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.
No measurements were reported for this outcome.
Measured by Elisa at participant level - only participant level data available; not summarized across group
| pg/ml | Surgical Candidate Baseline | Surgery Candidate Surgery | Surgical Candidate One Week | Surgical Candidate 4 Weeks | Surgical Candidate 6 Months |
|---|---|---|---|---|---|
| IPMN Adenoma-Part 1 | 60 | 70 | 70 | 130 | 100 |
| IPMN low-Part 2 | 170 | 90 | 10 | 40 | 10 |
| IPMN Invasive-Part 3 | 70 | 30 | 60 | 10 | 70 |
| IPMN NOS-Part 4 | 100 | 140 | 20 | 80 | 30 |
Measured by Elisa at participant level - only participant level data available; not summarized across group
| pg/ml | Surgical Candidate Baseline | Surgery Candidate Surgery | Surgical Candidate One Week | Surgical Candidate 4 Weeks | Surgical Candidate 6 Months |
|---|---|---|---|---|---|
| IPMN Adenoma-Part 1 | 196 | 177 | 354 | 431 | 522 |
| IPMN low-Part 2 | 257 | 201 | 153 | 594 | 366 |
| IPMN Invasive-Part 3 | 128 | NA | 850 | 453 | 184 |
| IPMN NOS-Part 4 | 131 | 100 | 184 | 417 | 88 |
Measured by Elisa at participant level - only participant level data available; not summarized across group
| pg/ml | Surgical Candidate Baseline | Surgery Candidate Surgery | Surgical Candidate One Week | Surgical Candidate 4 Weeks | Surgical Candidate 6 Months |
|---|---|---|---|---|---|
| IPMN Adenoma-Part 1 | 20 | 4 | 6.4 | 5.4 | 6.7 |
| IPMN low-Part 2 | 7 | 4.3 | 9.3 | 5.9 | 8.7 |
| IPMN Invasive-Part 3 | 2 | 3 | 11.8 | 5.1 | 8.3 |
| IPMN NOS-Part 4 | 9 | 3.4 | 7.2 | 4.3 | 1.8 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Surgical Candidate | — | 2/5 (40%) | 5/5 (100%) |
| Medical Candidate | — | — | — |
| Event | Surgical Candidate | Medical Candidate |
|---|---|---|
| NERVOUS SYSTEM DISORDERS - OTHER, [NEUROLEPTIC REACTION]Nervous system disorders | 1/5 | — |
| CARDIAC DISORDERS - OTHER, [CONGESTIVE HEART FAILURE]Cardiac disorders | 1/5 | — |
| Event | Surgical Candidate | Medical Candidate |
|---|---|---|
| DIARRHEAGastrointestinal disorders | 2/5 | — |
| FATIGUEGeneral disorders | 2/5 | — |
| COUGHRespiratory, thoracic and mediastinal disorders | 2/5 | — |
| EKG CHANGESCardiac disorders | 1/5 | — |
| PALPITATIONSCardiac disorders | 1/5 | — |
| ARRTHYTHMIACardiac disorders | 1/5 | — |
| ATRIAL FIBRILLATIONCardiac disorders | 1/5 | — |
| PANCREATIC FISTULAGastrointestinal disorders | 1/5 | — |
| PAINGastrointestinal disorders | 1/5 | — |
| EDEMA: LIMB SWELLING OF THE ARMS AND/OR LEGSGeneral disorders | 1/5 | — |
| Age, Categorical(participants) | Surgical Candidate | Medical Candidate | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 2 | — | 2 |
| >=65 years | 3 | — | 3 |
| Gender(participants) | Surgical Candidate | Medical Candidate | Total |
|---|---|---|---|
| Female | 0 | — | 0 |
| Male | 5 | — | 5 |
| Ethnicity (NIH/OMB)(participants) | Surgical Candidate | Medical Candidate | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 5 | — | 5 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(participants) | Surgical Candidate | Medical Candidate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | — | 1 |
| Black or African American | 0 | — | 0 |
| White | 4 | — | 4 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | Surgical Candidate | Medical Candidate | Total |
|---|---|---|---|
| United States | 5 | — | 5 |
| IPMN type(participants) | Surgical Candidate | Medical Candidate | Total |
|---|---|---|---|
| Adenoma | 1 | — | 1 |
| Low grade | 1 | — | 1 |
| Invasive | 1 | — | 1 |
| Not Otherwise Specified | 1 | — | 1 |
| Unknown | 1 | — | 1 |
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Indiana University School of Medicine