Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)

Pancreas Neoplasms Clinical Trial

Official title:

A Phase II Trial of Celecoxib in Patients With IPMN

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00198081
• Other study ID #: 0305-20
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 26, 2016
• Start date: September 2005
• Est. completion date: April 2012

Study information

• Verified date: February 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of IPMN

• ECOG Performance status of 0, 1, or 2

• Adequate liver function, bilirubin < 1.5 times ULN, ALT or AST < 2.5 times ULN

• Adequate renal function: creatinine < 1.8

• Must be at least 18

Exclusion Criteria:

• Use of COX-2 selective inhibitors within the last month

• More than occasional use of NSAIDS in last month (occasional use defined as up to twice weekly dosing)

• CA19-9 levels 1.5 times the ULN

• Active pancreatitis

• Taking sulphonylureas, fluconazole or lithium concomitantly

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreas Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• COX-2 Inhibitor 6-8 weeks prior to surgery
400 mg BID 6-8 weeks prior to surgery
• 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

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, surgery, 1 wk, 4 wks, and 6 months	No
Primary	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	Baseline, surgery, 1 wk, 4 wks, and 6 months	No
Primary	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	Baseline, surgery, 1 wk, 4 wks, and 6 months	No
Primary	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	Baseline, surgery, 1 wk, 4 wks, and 6 months	No
Secondary	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.	Baseline, 6 months, 1 year	No