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

A Phase II Trial of Celecoxib in Patients With IPMN

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.

Study Overview

• Status: Terminated
• Conditions: Pancreas Neoplasms
• Intervention / Treatment: Drug: COX-2 Inhibitor 6-8 weeks prior to surgery; Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical Candidate; COX-2 Inhibitor 6-8 weeks prior to surgery	Drug: COX-2 Inhibitor 6-8 weeks prior to surgery; 400 mg BID 6-8 weeks prior to surgery; Other Names: Celecoxib
Experimental: Medical Candidate; COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP	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; Other Names: Celecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months	Measured by Elisa at participant level - only participant level data available; not summarized across group	Baseline, surgery, 1 wk, 4 wks, and 6 months
Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months	Measured by Elisa at participant level - only participant level data available; not summarized across group	Baseline, surgery, 1 wk, 4 wks, and 6 months
Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months	Measured by Elisa at participant level - only participant level data available; not summarized across group	Baseline, surgery, 1 wk, 4 wks, and 6 months
Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months	Measured by Elisa at participant level - only participant level data available; not summarized across group	Baseline, surgery, 1 wk, 4 wks, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Changes in IPMN Progression.	Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.	Baseline, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Indiana University School of Medicine
• Investigators: Principal Investigator: Christian M. Schmidt, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: celecoxib for pancreas lesions
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Celecoxib; Cyclooxygenase 2 Inhibitors
• Other Study ID Numbers: 0305-20