Clinical trial NCT00198081: Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
Official title: A Phase II Trial of Celecoxib in Patients With IPMN
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreas Neoplasms
Keywords: celecoxib for pancreas lesions
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
timeFrame: Baseline, surgery, 1 wk, 4 wks, and 6 months
measure: Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
timeFrame: Baseline, surgery, 1 wk, 4 wks, and 6 months
measure: Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months
timeFrame: Baseline, surgery, 1 wk, 4 wks, and 6 months
measure: Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months
timeFrame: Baseline, surgery, 1 wk, 4 wks, and 6 months
Secondary outcomes:
measure: Number of Participants With Clinical Changes in IPMN Progression.
timeFrame: Baseline, 6 months, 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Christian M. Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: