Page last updated: 2024-10-25

eflornithine and Adenomatous Polyps

eflornithine has been researched along with Adenomatous Polyps in 3 studies

Eflornithine: An inhibitor of ORNITHINE DECARBOXYLASE, the rate limiting enzyme of the polyamine biosynthetic pathway.
eflornithine : A fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2.

Adenomatous Polyps: Benign neoplasms derived from glandular epithelium. (From Stedman, 25th ed)

Research Excerpts

ExcerptRelevanceReference
"A phase III clinical trial assessed the recurrence of adenomatous polyps after treatment for 36 months with difluoromethylornithine (DFMO) plus sulindac or matched placebos."5.13Longitudinal assessment of air conduction audiograms in a phase III clinical trial of difluoromethylornithine and sulindac for prevention of sporadic colorectal adenomas. ( Chen, WP; Fujikawa-Brooks, S; Gerner, EW; Gillen, DL; McLaren, CE; Meyskens, FL; Pelot, D, 2008)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (33.33)29.6817
2010's2 (66.67)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Mohammed, A1
Janakiram, NB1
Brewer, M1
Vedala, K1
Steele, VE1
Rao, CV1
Lynch, PM1
Burke, CA1
Phillips, R1
Morris, JS1
Slack, R1
Wang, X1
Liu, J1
Patterson, S1
Sinicrope, FA1
Rodriguez-Bigas, MA1
Half, E1
Bulow, S1
Latchford, A1
Clark, S1
Ross, WA1
Malone, B1
Hasson, H1
Richmond, E1
Hawk, E1
McLaren, CE1
Fujikawa-Brooks, S1
Chen, WP1
Gillen, DL1
Pelot, D1
Gerner, EW1
Meyskens, FL1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Two-Arm Phase II Chemoprevention Trial in Adenomatous Polyposis Coli Patients[NCT00033371]Phase 2205 participants (Actual)Interventional2001-12-13Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage Change in Global Colorectal Polyps Burden

Percentage Change in Global Colorectal Polyps burden (NCT00033371)
Timeframe: 6 months

Interventionpercentage change of total Polyps burden (Mean)
Arm I: Celecoxib and Placebo-27
Arm II: Celecoxib and Eflornithine-40

Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher

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. (NCT00033371)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
High-frequency hearing lossFatigueDiarrhoeaHeartburn/dyspepsiaMucositis/stomatitisNausea/vomitingGoutHeadache
Arm I:Celecoxib, 400 mg p.o. BID Plus DFMO Placebo ( 60 Partic4116411605
Arm II: Celecoxib, 400 mg p.o. BID Plus DFMO 0.5 gm/m2/Day Rou734215711

Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum

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. (NCT00033371)
Timeframe: Baseline up to 6 months

,
Interventionpercentage change in polyp count (Mean)
ITT AllITT MeasurableITT Evaluable
Arm I: Celecoxib and Placebo-1-110
Arm II: Celecoxib and Eflornithine-11-13-8

Trials

2 trials available for eflornithine and Adenomatous Polyps

ArticleYear
An international randomised trial of celecoxib versus celecoxib plus difluoromethylornithine in patients with familial adenomatous polyposis.
    Gut, 2016, Volume: 65, Issue:2

    Topics: Adenomatous Polyps; Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Celecoxib; Cy

2016
Longitudinal assessment of air conduction audiograms in a phase III clinical trial of difluoromethylornithine and sulindac for prevention of sporadic colorectal adenomas.
    Cancer prevention research (Philadelphia, Pa.), 2008, Volume: 1, Issue:7

    Topics: Adenomatous Polyps; Antineoplastic Combined Chemotherapy Protocols; Audiometry, Pure-Tone; Colonic N

2008

Other Studies

1 other study available for eflornithine and Adenomatous Polyps

ArticleYear
Multitargeted low-dose GLAD combination chemoprevention: a novel and promising approach to combat colon carcinogenesis.
    Neoplasia (New York, N.Y.), 2013, Volume: 15, Issue:5

    Topics: Adenomatous Polyps; Animals; Antineoplastic Combined Chemotherapy Protocols; Atorvastatin; Carcinoge

2013