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

NCT ID: NCT00198081

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Surgical Candidate

COX-2 Inhibitor 6-8 weeks prior to surgery

Group Type: EXPERIMENTAL

COX-2 Inhibitor 6-8 weeks prior to surgery

Intervention Type: DRUG

400 mg BID 6-8 weeks prior to surgery

Medical Candidate

COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP

Group Type: EXPERIMENTAL

COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP

Intervention Type: DRUG

400 mg BID for 6 months prior to follow-up EUS or ERCP

Interventions

COX-2 Inhibitor 6-8 weeks prior to surgery

400 mg BID 6-8 weeks prior to surgery

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Celecoxib; Celecoxib

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian M. Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0305-20

Identifier Type: -

Identifier Source: org_study_id