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

Condition(s) targeted: Pancreas Neoplasms

Intervention: celecoxib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Christian M. Schmidt, MD, Principal Investigator, Affiliation: Indiana University

Overall contact:
Christian M. Schmidt, MD, Phone: (317) 278-8349, Email: maxschmi@iupui.edu

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.

Official title: A Phase II Trial of Celecoxib in Patients With IPMN

Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Determine whether the COX-2 inhibitor celecoxib changes the IPMN tumor marker profile in serum, pancreatic fluid and tissue of patients with IPMN through gene and protein expression profiling studies.

Secondary outcome: Determine whether the COX-2 inhibitor celecoxib changes IPMN progression clinically.

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Christian M. Schmidt, MD, Phone: (317) 278-8349, Email: maxschmi@iupui.edu

Indiana University Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Christian M. Schmidt, MD, Phone: 317-278-8349, Email: maxschmi@iupui.edu
Sarah Dutkevitch, RN, Phone: 317-274-5495, Email: sdutkevi@iupui.edu
Christian M Schmidt, MD, Principal Investigator

Starting date: September 2005
Ending date: September 2014
Last updated: September 29, 2009