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

NCT00198081 | Terminated Phase 2 Results DMC

• 1 other identifier: 0305-20
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Neoplasms

Keywords

celecoxib for pancreas lesions

Outcome Measures

Primary Outcomes (4)

• Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months

  Measured by Elisa at participant level - only participant level data available; not summarized across group

  Baseline, surgery, 1 wk, 4 wks, and 6 months

• Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months

  Measured by Elisa at participant level - only participant level data available; not summarized across group

  Baseline, surgery, 1 wk, 4 wks, and 6 months

• Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months

  Measured by Elisa at participant level - only participant level data available; not summarized across group

  Baseline, surgery, 1 wk, 4 wks, and 6 months

• Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months

  Measured by Elisa at participant level - only participant level data available; not summarized across group

  Baseline, surgery, 1 wk, 4 wks, and 6 months

Secondary Outcomes (1)

• Number of Participants With Clinical Changes in IPMN Progression.

  Baseline, 6 months, 1 year

Study Arms (2)

Surgical Candidate

EXPERIMENTAL

COX-2 Inhibitor 6-8 weeks prior to surgery

Drug: COX-2 Inhibitor 6-8 weeks prior to surgery

Medical Candidate

EXPERIMENTAL

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

Interventions

COX-2 Inhibitor 6-8 weeks prior to surgery DRUG

400 mg BID 6-8 weeks prior to surgery

Also known as: Celecoxib

Surgical Candidate

COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP DRUG

400 mg BID for 6 months prior to follow-up EUS or ERCP

Also known as: Celecoxib

Medical Candidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cyclooxygenase 2 Inhibitors; Celecoxib; Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Christian M. Schmidt, MD
• Organization: Indiana University

maxschmi@iupui.edu

317-278-8349

Study Officials

• Christian M. Schmidt, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2005
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-02

Locations

US (1)