Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
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 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 ]
|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)|
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.
|Contact: Christian M. Schmidt, MD||(317) email@example.com|
|United States, Indiana|
|Indiana University Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Christian M. Schmidt, MD 317-278-8349 firstname.lastname@example.org|
|Contact: Sarah Dutkevitch, RN 317-274-5495 email@example.com|
|Principal Investigator: Christian M Schmidt, MD|
|Principal Investigator:||Christian M. Schmidt, MD||Indiana University|