Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
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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 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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 ]
- 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) |
-
Drug: celecoxib
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 |
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| Contact: Christian M. Schmidt, MD | (317) 278-8349 | maxschmi@iupui.edu |
| 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 | |
| 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: | April 1, 2013 |
| 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 May 23, 2013