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)
| Excerpt | Relevance | Reference |
|---|---|---|
| "A phase III clinical trial assessed the recurrence of adenomatous polyps after treatment for 36 months with difluoromethylornithine (DFMO) plus sulindac or matched placebos." | 5.13 | Longitudinal 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) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 1 (33.33) | 29.6817 |
| 2010's | 2 (66.67) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Mohammed, A | 1 |
| Janakiram, NB | 1 |
| Brewer, M | 1 |
| Vedala, K | 1 |
| Steele, VE | 1 |
| Rao, CV | 1 |
| Lynch, PM | 1 |
| Burke, CA | 1 |
| Phillips, R | 1 |
| Morris, JS | 1 |
| Slack, R | 1 |
| Wang, X | 1 |
| Liu, J | 1 |
| Patterson, S | 1 |
| Sinicrope, FA | 1 |
| Rodriguez-Bigas, MA | 1 |
| Half, E | 1 |
| Bulow, S | 1 |
| Latchford, A | 1 |
| Clark, S | 1 |
| Ross, WA | 1 |
| Malone, B | 1 |
| Hasson, H | 1 |
| Richmond, E | 1 |
| Hawk, E | 1 |
| McLaren, CE | 1 |
| Fujikawa-Brooks, S | 1 |
| Chen, WP | 1 |
| Gillen, DL | 1 |
| Pelot, D | 1 |
| Gerner, EW | 1 |
| Meyskens, FL | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Two-Arm Phase II Chemoprevention Trial in Adenomatous Polyposis Coli Patients[NCT00033371] | Phase 2 | 205 participants (Actual) | Interventional | 2001-12-13 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Percentage Change in Global Colorectal Polyps burden (NCT00033371)
Timeframe: 6 months
| Intervention | percentage change of total Polyps burden (Mean) |
|---|---|
| Arm I: Celecoxib and Placebo | -27 |
| Arm II: Celecoxib and Eflornithine | -40 |
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
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| High-frequency hearing loss | Fatigue | Diarrhoea | Heartburn/dyspepsia | Mucositis/stomatitis | Nausea/vomiting | Gout | Headache | |
| Arm I:Celecoxib, 400 mg p.o. BID Plus DFMO Placebo ( 60 Partic | 4 | 11 | 6 | 4 | 11 | 6 | 0 | 5 |
| Arm II: Celecoxib, 400 mg p.o. BID Plus DFMO 0.5 gm/m2/Day Rou | 7 | 3 | 4 | 2 | 15 | 7 | 1 | 1 |
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
| Intervention | percentage change in polyp count (Mean) | ||
|---|---|---|---|
| ITT All | ITT Measurable | ITT Evaluable | |
| Arm I: Celecoxib and Placebo | -1 | -1 | 10 |
| Arm II: Celecoxib and Eflornithine | -11 | -13 | -8 |
2 trials available for eflornithine and Adenomatous Polyps
| Article | Year |
|---|---|
An international randomised trial of celecoxib versus celecoxib plus difluoromethylornithine in patients with familial adenomatous polyposis.
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.
Topics: Adenomatous Polyps; Antineoplastic Combined Chemotherapy Protocols; Audiometry, Pure-Tone; Colonic N | 2008 |
1 other study available for eflornithine and Adenomatous Polyps
| Article | Year |
|---|---|
Multitargeted low-dose GLAD combination chemoprevention: a novel and promising approach to combat colon carcinogenesis.
Topics: Adenomatous Polyps; Animals; Antineoplastic Combined Chemotherapy Protocols; Atorvastatin; Carcinoge | 2013 |