A Phase II Trial of Celecoxib in Patients With IPMN
18 Years
N/A
Both
Pancreas Neoplasms
Trial Information
A Phase II Trial of Celecoxib in Patients With IPMN
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Christian M. Schmidt, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Indiana University
Authority:
United States: Institutional Review Board
Study ID:
0305-20
NCT ID:
NCT00198081
Start Date:
September 2005
Completion Date:
September 2021
Related Keywords:
- Pancreas Neoplasms
- celecoxib for pancreas lesions
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Indiana University Hospital | Indianapolis, Indiana 46202 |
