Trial · NCT00033371
Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis
NCT00033371, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-02-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. Trials, record NCT00033371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00033371
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis
- NCT number
- NCT00033371
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 205 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Colorectal Cancer, Familial Adenomatous Polyposis
- Interventions
- Celecoxib, Placebo, eflornithine, Laboratory biomarker analysis, Questionnaire administration
- First posted
- 2003-01-27
- Last updated
- 2020-09-29
- Results first posted
- 2015-02-04
- Limitations and caveats
Following reports of COX-2 inhibitor-associated cardiovascular toxicities, trial suspended from December 17, 2004 to March 18, 2005 pending reevaluation of cardiovascular risks, only two sites resumed the trial.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Baseline up to 6 months | Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie \[(6 months - baseline) x 100\]/baseline (%). For each participant, first were matched polyps between baseline \& 6 months by region and landmark and summed over all matched regions on number of polyps \>2 mm to calculate total number of polyps \>2 mm at baseline \& 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline \& 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days. |
| Primary | Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher | 6 months | To determine the relative tolerability and safety of celecoxib + DFMO in FAP study participants. Includes only adverse events that occurred in at least 5% of the patients or a patient exhibited at least 1 grade 3 toxicity. |
| Secondary | Percentage Change in Global Colorectal Polyps Burden | 6 months | Percentage Change in Global Colorectal Polyps burden |
| Secondary | Percent Change in the Area of Plaque-like Duodenal Polyps | 6 months | |
| Other | Global Duodenal Polyp Burden | 6 months | |
| Other | Percent Change in Polyp Size in Focal Area(s) of the Colorectum | Baseline up to 2 months after completion of study treatment |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Baseline up to 6 months | 112 patients were randomized to the study. Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information. | percentage change in polyp count | MEAN |
| PRIMARY | Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher | 6 months | Total of 57 participants in Arm II, 1 participant is missing AE data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change in Global Colorectal Polyps Burden | 6 months | A total of 89 participants had complete polyp information at baseline and 6 months. | percentage change of total Polyps burden | MEAN |
| SECONDARY | Percent Change in the Area of Plaque-like Duodenal Polyps | 6 months | The data was inevaluable to determine the percent change in the area of plaque-like duodenal polyps | ||
| OTHER_PRE_SPECIFIED | Global Duodenal Polyp Burden | 6 months | The data was inevaluable to determine the global duodenal polyp burden | ||
| OTHER_PRE_SPECIFIED | Percent Change in Polyp Size in Focal Area(s) of the Colorectum | Baseline up to 2 months after completion of study treatment | No data collected to determine the percentage change in polyp size in focal area(s) of the colorectum. |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Arm I: Celecoxib and Placebo | ITT All | -1 | Standard Error 0.11 | percentage change in polyp count |
| Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Arm II: Celecoxib and Eflornithine | ITT All | -11 | Standard Error 0.08 | percentage change in polyp count |
| Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Arm I: Celecoxib and Placebo | ITT Measurable | -1 | Standard Error 0.14 | percentage change in polyp count |
| Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Arm II: Celecoxib and Eflornithine | ITT Measurable | -13 | Standard Error 0.10 | percentage change in polyp count |
| Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Arm I: Celecoxib and Placebo | ITT Evaluable | 10 | Standard Error 0.18 | percentage change in polyp count |
| Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum | Arm II: Celecoxib and Eflornithine | ITT Evaluable | -8 | Standard Error 0.12 | percentage change in polyp count |
| Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher | Arm I:Celecoxib, 400 mg p.o. BID Plus DFMO Placebo ( 60 Partic | High-frequency hearing loss | 4 | Participants | |
| Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher | Arm II: Celecoxib, 400 mg p.o. BID Plus DFMO 0.5 gm/m2/Day Rou | High-frequency hearing loss | 7 | Participants | |
| Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher | Arm I:Celecoxib, 400 mg p.o. BID Plus DFMO Placebo ( 60 Partic | Fatigue | 11 | Participants | |
| Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher | Arm II: Celecoxib, 400 mg p.o. BID Plus DFMO 0.5 gm/m2/Day Rou | Fatigue | 3 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Celecoxib and Placebo | 55 | |
| Overall Study | STARTED | Arm II: Celecoxib and Eflornithine | 57 | |
| Overall Study | COMPLETED | Arm I: Celecoxib and Placebo | 49 | |
| Overall Study | COMPLETED | Arm II: Celecoxib and Eflornithine | 47 | |
| Overall Study | NOT COMPLETED | Arm I: Celecoxib and Placebo | 6 | |
| Overall Study | NOT COMPLETED | Arm II: Celecoxib and Eflornithine | 10 |
Source ClinicalTrials.gov
Adverse events280
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergies, seasonal | Immune system disorders | Arm I: Celecoxib and Placebo | 0 | 55 | |
| other | Allergies, seasonal | Immune system disorders | Arm II: Celecoxib and Eflornithine | 2 | 57 | |
| other | Allergic rhinitis | Immune system disorders | Arm I: Celecoxib and Placebo | 3 | 55 | |
| other | Allergic rhinitis | Immune system disorders | Arm II: Celecoxib and Eflornithine | 0 | 57 | |
| other | Allergic reaction (food) | Immune system disorders | Arm I: Celecoxib and Placebo | 0 | 55 | |
| other | Allergic reaction (food) | Immune system disorders | Arm II: Celecoxib and Eflornithine | 1 | 57 | |
| other | High Frequency Hearing loss | Ear and labyrinth disorders | Arm I: Celecoxib and Placebo | 5 | 55 | |
| other | High Frequency Hearing loss | Ear and labyrinth disorders | Arm II: Celecoxib and Eflornithine | 7 | 57 | |
| other | Otitis | Ear and labyrinth disorders | Arm I: Celecoxib and Placebo | 8 | 55 | |
| other | Otitis | Ear and labyrinth disorders | Arm II: Celecoxib and Eflornithine | 3 | 57 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Celecoxib and Placebo | ||
| Total, all-cause mortality | Arm II: Celecoxib and Eflornithine | ||
| Total, other adverse events | Arm I: Celecoxib and Placebo | 53 | 55 |
| Total, other adverse events | Arm II: Celecoxib and Eflornithine | 48 | 57 |
| Total, serious adverse events | Arm I: Celecoxib and Placebo | 0 | 55 |
| Total, serious adverse events | Arm II: Celecoxib and Eflornithine | 3 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25792707 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I: Celecoxib and Placebo vs Arm II: Celecoxib and Eflornithine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00033371
GET https://conductscience.org/api/trials/v1/NCT00033371/results?page=2