Primary Outcome Measures:
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine whether the COX-2 inhibitor celecoxib changes IPMN progression clinically. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Intervention Details:
Drug: celecoxib
For surgical candidates: Celecoxib 400 mg BID 6-8 weeks For Non-surgical candidates: Celecoxib 400 mg BID 6 months
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.