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Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00198081
Recruitment Status : Terminated (Lack of funding and personnel to conduct study.)
First Posted : September 20, 2005
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasms Drug: COX-2 Inhibitor 6-8 weeks prior to surgery Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Trial of Celecoxib in Patients With IPMN
Study Start Date : September 2005
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Surgical Candidate
COX-2 Inhibitor 6-8 weeks prior to surgery
 Drug: COX-2 Inhibitor 6-8 weeks prior to surgery
400 mg BID 6-8 weeks prior to surgery
Other Name: Celecoxib
Experimental: Medical Candidate
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
 Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
400 mg BID for 6 months prior to follow-up EUS or ERCP
Other Name: Celecoxib


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months [ Time Frame: Baseline, surgery, 1 wk, 4 wks, and 6 months ]
    Measured by Elisa at participant level - only participant level data available; not summarized across group

  2. Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months [ Time Frame: Baseline, surgery, 1 wk, 4 wks, and 6 months ]
    Measured by Elisa at participant level - only participant level data available; not summarized across group

  3. Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months [ Time Frame: Baseline, surgery, 1 wk, 4 wks, and 6 months ]
    Measured by Elisa at participant level - only participant level data available; not summarized across group

  4. Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months [ Time Frame: Baseline, surgery, 1 wk, 4 wks, and 6 months ]
    Measured by Elisa at participant level - only participant level data available; not summarized across group


Secondary Outcome Measures :
  1. Number of Participants With Clinical Changes in IPMN Progression. [ Time Frame: Baseline, 6 months, 1 year ]
    Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198081


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: Christian M. Schmidt, MD Indiana University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00198081    
Other Study ID Numbers: 0305-20
First Posted: September 20, 2005    Key Record Dates
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016
Last Verified: February 2016
Keywords provided by Indiana University ( Indiana University School of Medicine ):
celecoxib for pancreas lesions
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action