Not provided
Not provided
Not provided
Not provided
Not provided
Lack of funding and personnel to conduct study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Candidate | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COX-2 Inhibitor 6-8 weeks prior to surgery | Drug | 400 mg BID 6-8 weeks prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Changes in IPMN Progression. | 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. | Baseline, 6 months, 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian M. Schmidt, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Candidate | COX-2 Inhibitor 6-8 weeks prior to surgery COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery |
| FG001 | Medical Candidate | COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Candidate | COX-2 Inhibitor 6-8 weeks prior to surgery COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery |
| BG001 | Medical Candidate | COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | pg/ml | Baseline, surgery, 1 wk, 4 wks, and 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Candidate | COX-2 Inhibitor 6-8 weeks prior to surgery COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NERVOUS SYSTEM DISORDERS - OTHER, [NEUROLEPTIC REACTION] | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EKG CHANGES | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian M. Schmidt, MD | Indiana University | 317-278-8349 | maxschmi@iupui.edu |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D052246 | Cyclooxygenase 2 Inhibitors |
| D000068579 | Celecoxib |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D016861 | Cyclooxygenase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Ethnicity (NIH/OMB) | Number | participants |
|
| Race (NIH/OMB) | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| IPMN type | Number | participants |
|
| Surgical Candidate One Week |
COX-2 Inhibitor 6-8 weeks prior to surgery COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery |
| OG003 | Surgical Candidate 4 Weeks | COX-2 Inhibitor 6-8 weeks prior to surgery COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery |
| OG004 | Surgical Candidate 6 Months | COX-2 Inhibitor 6-8 weeks prior to surgery COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery |
|
|
| Secondary | Number of Participants With Clinical Changes in IPMN Progression. | 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. | Data never collected for surgical arm; medical arm of study never initiated. | Posted | Baseline, 6 months, 1 year |
|
|
| Primary | 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 | Posted | Number | pg/ml | Baseline, surgery, 1 wk, 4 wks, and 6 months |
|
|
|
| Primary | 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 | Posted | Number | pg/ml | Baseline, surgery, 1 wk, 4 wks, and 6 months |
|
|
|
| Primary | 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 | Posted | Number | pg/ml | Baseline, surgery, 1 wk, 4 wks, and 6 months |
|
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| EG001 | Medical Candidate | COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP 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 | 0 | 0 | 0 | 0 |
| CARDIAC DISORDERS - OTHER, [CONGESTIVE HEART FAILURE] | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| ARRTHYTHMIA | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| PANCREATIC FISTULA | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| PAIN | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| EDEMA: LIMB SWELLING OF THE ARMS AND/OR LEGS | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| FLU-TYPE SYMPTOMS (INCLUDING BODY ACHES, FEVER, CHILLS, TIREDNESS,LOSS OF APPETITE, COUGH) | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| SEROMA | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| INR INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, [RUNNY NOSE] | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D020164 | Chemical Actions and Uses |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| IPMN low-Part 2 |
|
| IPMN Invasive-Part 3 |
|
| IPMN NOS-Part 4 |
|
| IPMN low-Part 2 |
|
| IPMN Invasive-Part 3 |
|
| IPMN NOS-Part 4 |
|
| IPMN low-Part 2 |
|
| IPMN Invasive-Part 3 |
|
| IPMN NOS-Part 4 |
|