NCT00198081

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

A Phase II Trial of Celecoxib in Patients With IPMN

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pancreas Neoplasms

Interventions

Type	Name	Description
DRUG	COX-2 Inhibitor 6-8 weeks prior to surgery	400 mg BID 6-8 weeks prior to surgery
DRUG	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

Timeline

• Start date: 2005-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2005-09-20
• Last updated: 2016-02-29
• Results posted: 2016-02-29

Locations

1 site across 1 country: United States