Colorectal CancerPhase 2/3NCT00026468
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
A Phase 2/3 study testing exisulind in people with Colorectal Cancer and Small Intestine Cancer, run by University of Utah.
Trial summary
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis. PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Small Intestine Cancer
- What is being tested?
- exisulind
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Jul 1999
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- One of the following diagnosis:
- Diagnosis of familial adenomatous polyposis
- Prior total or subtotal colectomy
- Attenuated adenomatous polyposis coli
- May have colon intact
- 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm^3
- No active hematologic disease
Hepatic:
- AST and ALT less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 1.5 times ULN
- No active hepatic disease
Renal:
- Creatinine less than 1.5 mg/dL
- No active renal disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active peptic ulcer disease
- No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival
- No prisoners or institutionalized patients
- No known allergy to sulindac or related compounds
- No active internal malignancy within the past 5 years
- No alcohol or drug abuse within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months
- No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine)
- Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)
About this study
Official title: Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
Read the detailed description
OBJECTIVES:
- Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis.
- Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral exisulind 4 times daily.
- Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
- Conditions
- Colorectal Cancer, Small Intestine Cancer
- Being tested
- exisulind
- Keywords
- colon cancer, rectal cancer, small intestine cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exisulindDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 1999
- Primary completionJul 1999
- Study completionJul 1999
Why it stopped: Principle Investigator has left the University.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- James A. DiSario, MD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026468
- Sponsor's protocol ID
- CDR0000069032
- Other IDs
- R01CA080852, P30CA042014, UUMC-IRB-5999-96, NCI-H01-0079
- Status last verified
- Jul 2013
- First submitted
- 9 Nov 2001
- Last updated
- 24 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT00026468
- Acronym / sponsor ID
- CDR0000069032
- Conditions
- Colorectal Cancer, Small Intestine Cancer
- Keywords
- colon cancer, rectal cancer, small intestine cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principle Investigator has left the University.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1999
- Primary completion
- Jul 1999 (actual)
- Study completion
- Jul 1999 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
Detailed description
OBJECTIVES:
- Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis.
- Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral exisulind 4 times daily.
- Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| exisulind | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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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.
James A. DiSario, MD study chair
University of Utah
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing exisulind in people with Colorectal Cancer and Small Intestine Cancer, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 24 Jul 2013.