Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs) - Full Text View

Sponsor:	Indiana University School of Medicine
Information provided by (Responsible Party):	Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:	NCT00198081

Purpose

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.

Condition	Intervention	Phase
Pancreas Neoplasms	Drug: celecoxib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase II Trial of Celecoxib in Patients With IPMN

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Indiana University:

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 ]

Estimated Enrollment:	30
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2021
Estimated Primary Completion Date:	September 2020 (Final data collection date for primary outcome measure)

Intervention Details:

For surgical candidates: Celecoxib 400 mg BID 6-8 weeks For Non-surgical candidates: Celecoxib 400 mg BID 6 months

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198081

Contacts

Contact: Christian M. Schmidt, MD

(317) 278-8349

maxschmi@iupui.edu

Locations

United States, Indiana
Indiana University Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Christian M. Schmidt, MD 317-278-8349 maxschmi@iupui.edu
Contact: Sarah Dutkevitch, RN 317-274-5495 sdutkevi@iupui.edu
Principal Investigator: Christian M Schmidt, MD

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Christian M. Schmidt, MD

Indiana University

More Information

No publications provided

Responsible Party:	Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:	NCT00198081 History of Changes
Other Study ID Numbers:	0305-20
Study First Received:	September 12, 2005
Last Updated:	September 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

celecoxib for pancreas lesions

Additional relevant MeSH terms:

Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012