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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Indiana University |
| 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: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Trial of Celecoxib in Patients With IPMN |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2012 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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
| Responsible Party: | Indiana University ( Christian M. Schmidt, Principal Investigator ) |
| Study ID Numbers: | 0305-20 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00198081 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
celecoxib for pancreas lesions |
|
Anti-Inflammatory Agents Digestive System Neoplasms Celecoxib Molecular Mechanisms of Pharmacological Action Pancreatic Neoplasms Physiological Effects of Drugs Cyclooxygenase Inhibitors Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Digestive System Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Pancreatic Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Endocrine Gland Neoplasms |