Pancreas NeoplasmsPhase 2NCT00198081
Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
A Phase 2 study testing COX-2 Inhibitor 6-8 weeks prior to surgery and COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP in people with Pancreas Neoplasms, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasms
- What is being tested?
- COX-2 Inhibitor 6-8 weeks prior to surgery and COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: A Phase II Trial of Celecoxib in Patients With IPMN
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.
Read the 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.
- Conditions
- Pancreas Neoplasms
- Being tested
- COX-2 Inhibitor 6-8 weeks prior to surgery, COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
- Keywords
- celecoxib for pancreas lesions
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COX-2 Inhibitor 6-8 weeks prior to surgeryDrug
Also called Celecoxib
400 mg BID 6-8 weeks prior to surgery
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCPDrug
Also called Celecoxib
400 mg BID for 6 months prior to follow-up EUS or ERCP
| Study group | Role | What they receive |
|---|---|---|
| Surgical Candidate | Experimental | COX-2 Inhibitor 6-8 weeks prior to surgery Receives: 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 Receives: Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, surgery, 1 wk, 4 wks, and 6 months
Secondary outcomes (1)
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.
Measured: Baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Lack of funding and personnel to conduct study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreas NeoplasmsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian M. Schmidt, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198081
- Sponsor's protocol ID
- 0305-20
- Status last verified
- Feb 2016
- First submitted
- 12 Sep 2005
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Celecoxib in Patients With IPMN
- ClinicalTrials.gov ID
- NCT00198081
- Acronym / sponsor ID
- 0305-20
- Conditions
- Pancreas Neoplasms
- Keywords
- celecoxib for pancreas lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and personnel to conduct study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Candidate | Experimental | Drug: COX-2 Inhibitor 6-8 weeks prior to surgeryCOX-2 Inhibitor 6-8 weeks prior to surgery |
| Medical Candidate | Experimental | Drug: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCPCOX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COX-2 Inhibitor 6-8 weeks prior to surgeryAlso: Celecoxib400 mg BID 6-8 weeks prior to surgery | Drug | Surgical Candidate |
| COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCPAlso: Celecoxib400 mg BID for 6 months prior to follow-up EUS or ERCP | Drug | Medical Candidate |
Primary outcome
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
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
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
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
1 secondary outcome
Number of Participants With Clinical Changes in IPMN Progression.
Time frame: Baseline, 6 months, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian M. Schmidt, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COX-2 Inhibitor 6-8 weeks prior to surgery and COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP in people with Pancreas Neoplasms, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.