Precancerous ConditionPhase 3NCT00118365
Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
A Phase 3 study testing eflornithine, sulindac and laboratory biomarker analysis in people with Precancerous Condition, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Precancerous Condition
- What is being tested?
- eflornithine, sulindac and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Aug 2008
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria:
- History of >= 1 surgically resected adenomatous polyp of the colon measuring >= 3 mm within the past 5 years
- Screening colonoscopy performed within the past 6 months
- All polyps must have been removed during colonoscopy, pathologically examined, and archived
- No prior surgical resection removing > 40 cm of the colon
- No personal or family history of familial polyposis or hereditary non-polyposis colon cancer
- SWOG 0-1
- Bilirubin =< 2.0 mg/dL
- AST and ALT =< 2 times normal
- Creatinine =< 1.5 mg/dL
- Urine protein =<, urine casts 0-3, urine WBC and RBC count 0-5 cells by urinalysis
- No history of inflammatory bowel disease
- No gastric or duodenal ulcers within the past 12 months
- Gastric or duodenal ulcers that were adequately treated > 24 months ago are allowed
- No symptomatic gastric or duodenal ulcers
- Not pregnant or nursing
- Negative pregnancy test
- Must have regional geographic stability over the next 36 months
- Pure tone audiometry evaluation normal
- Patients with >= 20 dB of uncorrectable hearing loss (for age) of any 2 contiguous frequencies are not allowed
- No invasive malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, level I (or Breslow < 0.76 mm) cutaneous melanoma, Duke's A colon cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia
- No severe metabolic disorder
- No other significant acute or chronic disease that would preclude study participation
- No history of abnormal wound healing or repair
- No conditions that would confer risk of abnormal wound healing or repair
- No history of allergy to NSAIDs or eflornithine
- No concurrent chemotherapy
- No concurrent corticosteroids on a regular or predictable intermittent basis
- No concurrent radiotherapy
- Concurrent calcium supplements (=< 1,000 mg/day) allowed
- Concurrent lipid-lowering drugs (i.e., high-dose statins) allowed
- No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular or predictable intermittent basis
- Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 mg/day) allowed
- No concurrent anticoagulants on a regular or predictable intermittent basis
- No concurrent treatment for gastric or duodenal ulcers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868
About this study
Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.
II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.
III. Compare the rate of side effects in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).
Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral double placebo once daily.
Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.
In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
- Conditions
- Precancerous Condition
- Being tested
- placebo, eflornithine, sulindac, laboratory biomarker analysis
- Medical subject headings
- Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called PLCB
Given orally
eflornithineDrug
Also called 2-difluoromethylornithine, DFMO, difluromethylornithine
Given orally
sulindacDrug
Also called Aflodac, Algocetil, Clinoril, SULIN
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm II (placebo) | Placebo comparator | Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. Receives: Other: placebo; Other: laboratory biomarker analysis |
| Arm I (eflornithine and sulindac) | Experimental | Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. Receives: Drug: eflornithine; Drug: sulindac; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Any Adenoma at the End of the Study
Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.
Measured: Up to 36 months
Secondary outcomes (20)
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment
This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.
Measured: Up to 36 months
Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment
The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.
Measured: Up 36 months
Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment
The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.
In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.
The analysis cohort is based on the participants whose data are available and complete.
Measured: Up 36 months
Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment
PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
Measured: Up to 36 months
Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment
Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
Measured: Up to 36 months
Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment
Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
Measured: Up to 36 months
Adverse Events With a Grade of 3 and Above
Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.
Per protocol, not all grade 3 events are considered as serious events.
Measured: Up to 36 months
Baseline Putrescine by ODC Genotype
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: Baseline
Baseline Spermidine by ODC Genotype
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: Baseline
Baseline Spermine by ODC Genotype
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: Baseline
At the End of the Study - Putrescine Response by ODC Genotype
Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: At the end of the study
At the End of the Study - Spermidine Response by ODC Genotype
Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: At the end of the study
At the End of the Study - Spermine Response by ODC Genotype
Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: At the end of the study
Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Measured: Up to 36 months
Biomarker in Adenoma: Apoptosis
Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.
Measured: At the end of the study
Biomarker in Adenoma - Ki-67
Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates
Measured: At the end of the study
Biomarker in Adenoma: CEA
carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.
Measured: At the end of the study
Biomarker in Adenoma: Sialyl-TN (B72.3)
sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.
Measured: At the end of the study
Biomarker in Adenoma - p53
Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.
Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene.
Measured: At the end of the study
Biomarker in Adenoma: Bcl-2
bcl-2 is the anti-apoptotic protein BCL2
Measured: At the end of the study, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startJul 1998
- Primary completionAug 2008
- Study completionAug 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frank Meyskens, Principal investigator, University of California Medical Center At Irvine-Orange Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118365
- Sponsor's protocol ID
- NCI-2009-00880
- Other IDs
- UCI 97-05, R01CA088078
- Status last verified
- Feb 2014
- First submitted
- 8 Jul 2005
- Last updated
- 22 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Thompson PA, Wertheim BC, Zell JA, Chen WP, McLaren CE, LaFleur BJ, Meyskens FL, Gerner EW. Levels of rectal mucosal polyamines and prostaglandin E2 predict ability of DFMO and sulindac to prevent colorectal adenoma. Gastroenterology. 2010 Sep;139(3):797-805, 805.e1. doi: 10.1053/j.gastro.2010.06.005. Epub 2010 Jun 9.
PubMed 20538001
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon
- ClinicalTrials.gov ID
- NCT00118365
- Acronym / sponsor ID
- NCI-2009-00880
- Conditions
- Precancerous Condition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 1998
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 22 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
Detailed description
PRIMARY OBJECTIVES:
- Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.
II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.
III. Compare the rate of side effects in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).
Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral double placebo once daily.
Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.
In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: laboratory biomarker analysisPatients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. |
| Arm I (eflornithine and sulindac) | Experimental | Drug: eflornithine, Drug: sulindac, Other: laboratory biomarker analysisPatients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. |
Who may qualify
- Ages
- 40 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 |
|---|---|---|
| placeboAlso: PLCBGiven orally | Other | Arm II (placebo) |
| eflornithineAlso: 2-difluoromethylornithine, DFMO, difluromethylornithineGiven orally | Drug | Arm I (eflornithine and sulindac) |
| sulindacAlso: Aflodac, Algocetil, Clinoril, SULINGiven orally | Drug | Arm I (eflornithine and sulindac) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (eflornithine and sulindac), Arm II (placebo) |
Primary outcome
Detection of Any Adenoma at the End of the Study
Time frame: Up to 36 months
Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.
20 secondary outcomes
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment
Time frame: Up to 36 months
Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment
Time frame: Up 36 months
Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment
Time frame: Up 36 months
Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment
Time frame: Up to 36 months
Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment
Time frame: Up to 36 months
Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment
Time frame: Up to 36 months
Adverse Events With a Grade of 3 and Above
Time frame: Up to 36 months
Baseline Putrescine by ODC Genotype
Time frame: Baseline
Baseline Spermidine by ODC Genotype
Time frame: Baseline
Baseline Spermine by ODC Genotype
Time frame: Baseline
At the End of the Study - Putrescine Response by ODC Genotype
Time frame: At the end of the study
At the End of the Study - Spermidine Response by ODC Genotype
Time frame: At the end of the study
At the End of the Study - Spermine Response by ODC Genotype
Time frame: At the end of the study
Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group
Time frame: Up to 36 months
Biomarker in Adenoma: Apoptosis
Time frame: At the end of the study
Biomarker in Adenoma - Ki-67
Time frame: At the end of the study
Biomarker in Adenoma: CEA
Time frame: At the end of the study
Biomarker in Adenoma: Sialyl-TN (B72.3)
Time frame: At the end of the study
Biomarker in Adenoma - p53
Time frame: At the end of the study
Biomarker in Adenoma: Bcl-2
Time frame: At the end of the study, up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20538001Thompson PA, Wertheim BC, Zell JA, Chen WP, McLaren CE, LaFleur BJ, Meyskens FL, Gerner EW. Levels of rectal mucosal polyamines and prostaglandin E2 predict ability of DFMO and sulindac to prevent colorectal adenoma. Gastroenterology. 2010 Sep;139(3):797-805, 805.e1. doi: 10.1053/j.gastro.2010.06.005. Epub 2010 Jun 9.
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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.
Frank Meyskens principal investigator
University of California Medical Center At Irvine-Orange Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eflornithine, sulindac and laboratory biomarker analysis in people with Precancerous Condition, run by National Cancer Institute (NCI) 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?
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: finished, as of the sponsor's last update on 22 Jan 2015. 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. Some participants in this study may receive a placebo. 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 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?
Yes. Results are posted in the registry (first posted 22 Jan 2015). 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?
Detection of Any Adenoma at the End of the Study (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00118365, which also lists 1 linked publication.
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 22 Jan 2015.