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

Indiana University School of Medicine

Status and phase: Terminated; Phase 2

Conditions: Pancreas Neoplasms

Treatments: Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP; Drug: COX-2 Inhibitor 6-8 weeks prior to surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00198081

0305-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Surgical Candidate

Experimental group

Description:

COX-2 Inhibitor 6-8 weeks prior to surgery

Treatment:

Drug: COX-2 Inhibitor 6-8 weeks prior to surgery

Medical Candidate

Experimental group

Description:

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

Treatment:

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