eflornithine has been researched along with Colonic Neoplasms in 80 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.
Colonic Neoplasms: Tumors or cancer of the COLON.
| Excerpt | Relevance | Reference |
|---|---|---|
| "We have investigated effects of alpha-difluoromethylornithine (DFMO), both as a single agent and in combination with 5-fluorouracil (5-FU) against a human colon tumor xenograft (T6) grown as primary tissue culture in serum-free medium and in combination with doxorubicin (DX) against a human lung adenocarcinoma cell line (A549)." | 7.68 | In vitro response of a human colon tumor xenograft and a lung adenocarcinoma cell line to alpha-difluoromethylornithine alone and in combination with 5-fluorouracil and doxorubicin. ( Atabek, U; Zirvi, KA, 1991) |
| "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) |
| "We have investigated effects of alpha-difluoromethylornithine (DFMO), both as a single agent and in combination with 5-fluorouracil (5-FU) against a human colon tumor xenograft (T6) grown as primary tissue culture in serum-free medium and in combination with doxorubicin (DX) against a human lung adenocarcinoma cell line (A549)." | 3.68 | In vitro response of a human colon tumor xenograft and a lung adenocarcinoma cell line to alpha-difluoromethylornithine alone and in combination with 5-fluorouracil and doxorubicin. ( Atabek, U; Zirvi, KA, 1991) |
| " The dosage of PXM 10 mg q." | 2.69 | Phase I chemoprevention study of piroxicam and alpha-difluoromethylornithine. ( Blair, IA; Carbone, PP; Douglas, JA; Larson, PO; Pomplun, M; Tutsch, KD; Verma, AK, 1998) |
| " DFMO has shown a dose-response effect in tumor inhibition in mice." | 2.67 | Randomized phase I chemoprevention dose-seeking study of alpha-difluoromethylornithine. ( Carbone, PP; Carey, P; Gilmore, D; Love, RR; Pomplun, M; Tutsch, KD; Verma, AK; Wilding, G, 1993) |
| "In spite of improvements in care of colon cancer patients, prevention may enable potential patients to avoid cancer therapy." | 2.45 | Nutrition and colon cancer prevention. ( Marshall, JR, 2009) |
| "Recent clinical cancer chemoprevention trials, using dose de-escalation designs, indicate that DFMO can be given over long periods of time at low doses that suppress polyamine contents in gastrointestinal and other epithelial tissues but cause no detectable hearing loss or other side effects." | 2.40 | Development of difluoromethylornithine (DFMO) as a chemoprevention agent. ( Gerner, EW; Meyskens, FL, 1999) |
| "As case study, colon cancer HT-29 cells, a human cell model to investigate colon cancer, are employed." | 1.42 | Metabolomics of adherent mammalian cells by capillary electrophoresis-mass spectrometry: HT-29 cells as case study. ( Campone, L; Cifuentes, A; García-Cañas, V; Ibáñez, C; Piccinelli, AL; Simó, C; Valdés, A, 2015) |
| "Phospho-sulindac (PS; OXT-328) prevents colon cancer in mice, especially when combined with difluoromethylornithine (DFMO)." | 1.38 | The metabolism and pharmacokinetics of phospho-sulindac (OXT-328) and the effect of difluoromethylornithine. ( Alston, N; Constantinides, PP; Huang, L; Kopelovich, L; Mackenzie, GG; Murray, OT; Nie, T; Ouyang, N; Rigas, B; Sun, Y; Xie, G; Zhu, C, 2012) |
| " Study results show that P-S/DFMO is an efficacious drug combination for colon cancer prevention and also show the safety of P-S, which may overcome the limiting side effects of conventional sulindac." | 1.37 | Phospho-sulindac (OXT-328) combined with difluoromethylornithine prevents colon cancer in mice. ( Huang, L; Komninou, D; Kopelovich, L; Mackenzie, GG; Ouyang, N; Rigas, B; Sun, Y; Vrankova, K; Xie, G, 2011) |
| " However, chronic administration of NSAIDs is associated with significant side effects, mainly of the gastrointestinal tract." | 1.36 | Phospho-sulindac (OXT-328), a novel sulindac derivative, is safe and effective in colon cancer prevention in mice. ( Gupta, RC; Huang, L; Johnson, F; Komninou, D; Kopelovich, L; Mackenzie, GG; Ouyang, N; Rigas, B; Sun, Y; Xie, G, 2010) |
| "Clinical familial adenomatous polyposis (FAP) syndrome represents a high risk pre-invasive precursor for colon cancer, and is characterized by germ line mutation in the adenomatous polyposis coli (APC) tumor suppressor gene." | 1.35 | Novel cell culture model for prevention of carcinogenic risk in familial adenomatous polyposis syndrome. ( Katdare, M; Telang, N, 2009) |
| "The majority of colon cancers have somatic mutations in the APC (adenomatous polyposis coli) tumour-suppressor gene." | 1.34 | Impact of dietary amino acids and polyamines on intestinal carcinogenesis and chemoprevention in mouse models. ( Gerner, EW, 2007) |
| "Hence, agents that prevented colon cancer decreased the mitotic index and altered the expression of c-myc, p16 and p27 suggesting that modulation in the expression of these genes are potential biomarkers for chemopreventive activity." | 1.31 | Altered expression of c-myc, p16 and p27 in rat colon tumors and its reversal by short-term treatment with chemopreventive agents. ( Kramer, PM; Lubet, RA; Pereira, MA; Steele, VE; Tao, L; Wang, W; Yang, S, 2002) |
| "The dose-response relationship in male F344 rats was determined for the ability of aspirin administered in the diet to prevent azoxymethane (AOM)-induced colon cancer and aberrant crypt foci (ACF) and to reduce prostaglandin E2 (PGE2) levels." | 1.30 | Prevention by aspirin and its combination with alpha-difluoromethylornithine of azoxymethane-induced tumors, aberrant crypt foci and prostaglandin E2 levels in rat colon. ( Conran, P; Hawk, EE; Kelloff, GJ; Kramer, PM; Li, H; Lubet, RA; Pereira, MA; Schut, HA; Steele, VE, 1999) |
| "Rat colon neoplasms are distributed 60% in the distal colon (DC) and 40% in the proximal colon (PC), similar to distribution of colon cancers in the industrialized world." | 1.29 | Regional chemoprevention of carcinogen-induced tumors in rat colon. ( Holt, PR; Liu, T; Mokuolu, AO; Rao, CV; Reddy, BS, 1995) |
| "once weekly for 20 wk to induce colon cancer." | 1.28 | Reduced growth rate of dimethylhydrazine-induced colon tumors in rats. ( Koike, T; Shibusawa, M; Tsunoda, A; Tsunoda, Y; Yasuda, N, 1992) |
| "A human colon cancer cell line Hce-8693 was heterotransplanted in nude mice." | 1.28 | [Inhibition by polyamine biosynthesis inhibitor DFMO of the growth of transplanted human colon cancer in nude mice]. ( Wang, M, 1991) |
| " The dose-response curve for ODC activation by VIP indicates an EC50 value of 0." | 1.28 | Involvement of ornithine decarboxylase in the control of proliferation of the HT29 human colon cancer cell line. Effect of vasoactive intestinal peptide on enzyme activity. ( Cazenave, Y; Denis-Pouxviel, C; Gamet, L; Murat, JC; Trocheris, V, 1991) |
| "Flavone acetic acid (FAA) is a novel antitumor agent which appears to work through a different mechanism than the conventional chemotherapeutic agents." | 1.28 | Combination of flavone acetic acid (FAA) with adriamycin, cis-platinum and difluoromethylornithine (DFMO) in vitro against human colon cancer cells. ( Bernabei, A; Corbett, TH; Freedland, C; Luk, GD; Neelam, SS; Thompson, R, 1990) |
| "Throughout the experiment, 50 colon cancers developed in 16 DMH-treated mice (mean, 3." | 1.27 | Inhibition of ornithine decarboxylase with 2-difluoromethylornithine: reduced incidence of dimethylhydrazine-induced colon tumors in mice. ( Diekema, KA; King, WW; Kingsnorth, AN; Malt, RA; McCann, PP; Ross, JS, 1983) |
| "CsA had inhibitory effects on MC-26 colon cancer growth which were similar to DFMO; these effects were blocked by the addition of the polyamine, putrescine." | 1.27 | Effects of cyclosporine and alpha-difluoromethylornithine on the growth of mouse colon cancer in vitro. ( Barranco, SC; Saydjari, R; Thompson, JC; Townsend, CM, 1987) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 19 (23.75) | 18.7374 |
| 1990's | 32 (40.00) | 18.2507 |
| 2000's | 17 (21.25) | 29.6817 |
| 2010's | 12 (15.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Gerner, EW | 13 |
| Bruckheimer, E | 1 |
| Cohen, A | 2 |
| Mohammed, A | 2 |
| Janakiram, NB | 2 |
| Brewer, M | 2 |
| Vedala, K | 1 |
| Steele, VE | 5 |
| Rao, CV | 4 |
| Ibáñez, C | 1 |
| Simó, C | 1 |
| Valdés, A | 1 |
| Campone, L | 1 |
| Piccinelli, AL | 1 |
| García-Cañas, V | 1 |
| Cifuentes, A | 1 |
| Renaud, S | 1 |
| Corcé, V | 1 |
| Cannie, I | 1 |
| Ropert, M | 1 |
| Lepage, S | 1 |
| Loréal, O | 1 |
| Deniaud, D | 1 |
| Gaboriau, F | 1 |
| Zell, J | 1 |
| You, YN | 1 |
| Boughey, JC | 1 |
| Burke, CA | 1 |
| Dekker, E | 1 |
| Samadder, NJ | 1 |
| Stoffel, E | 1 |
| Bryant, T | 1 |
| Zhang, Y | 1 |
| Duff, A | 1 |
| Biddick, L | 1 |
| Singh, A | 1 |
| Lightfoot, S | 1 |
| McLaren, CE | 1 |
| Fujikawa-Brooks, S | 1 |
| Chen, WP | 1 |
| Gillen, DL | 1 |
| Pelot, D | 3 |
| Meyskens, FL | 6 |
| Telang, N | 1 |
| Katdare, M | 1 |
| Devita, VT | 1 |
| Marshall, JR | 1 |
| Uemura, T | 1 |
| Stringer, DE | 2 |
| Blohm-Mangone, KA | 2 |
| Mackenzie, GG | 4 |
| Sun, Y | 4 |
| Huang, L | 4 |
| Xie, G | 4 |
| Ouyang, N | 3 |
| Gupta, RC | 1 |
| Johnson, F | 1 |
| Komninou, D | 3 |
| Kopelovich, L | 3 |
| Rigas, B | 4 |
| Zhu, C | 2 |
| Qiao, G | 1 |
| Vrankova, K | 1 |
| Nie, T | 1 |
| Alston, N | 1 |
| Murray, OT | 1 |
| Constantinides, PP | 1 |
| Tao, L | 2 |
| Kramer, PM | 2 |
| Wang, W | 2 |
| Yang, S | 1 |
| Lubet, RA | 3 |
| Pereira, MA | 4 |
| Hudson, EA | 1 |
| Howells, LM | 1 |
| Gallacher-Horley, B | 1 |
| Fox, LH | 1 |
| Gescher, A | 1 |
| Manson, MM | 1 |
| Ignatenko, NA | 4 |
| Zhang, H | 1 |
| Watts, GS | 1 |
| Skovan, BA | 1 |
| Reddy, BS | 7 |
| Li, Y | 1 |
| Umar, A | 2 |
| Nemoto, T | 1 |
| Kubota, S | 1 |
| Ishida, H | 1 |
| Murata, N | 1 |
| Hashimoto, D | 1 |
| Lance, P | 2 |
| Hurley, LH | 1 |
| Goldschmid, S | 1 |
| Raul, F | 1 |
| Gosse, F | 1 |
| Osswald, AB | 1 |
| Bouhadjar, M | 1 |
| Foltzer-Jourdainne, C | 1 |
| Marescaux, J | 1 |
| Soler, L | 1 |
| Tuma, R | 1 |
| Warrell, RP | 1 |
| Burchenal, JH | 1 |
| Kingsnorth, AN | 2 |
| King, WW | 1 |
| Diekema, KA | 1 |
| McCann, PP | 1 |
| Ross, JS | 2 |
| Malt, RA | 2 |
| Liu, T | 1 |
| Mokuolu, AO | 1 |
| Holt, PR | 1 |
| Wallon, UM | 1 |
| Shassetz, LR | 1 |
| Cress, AE | 1 |
| Bowden, GT | 1 |
| Singh, J | 2 |
| Kulkarni, N | 1 |
| Kelloff, G | 4 |
| McGarrity, TJ | 1 |
| Peiffer, LP | 1 |
| Smith, JP | 1 |
| Kramer, ST | 1 |
| Demers, LM | 1 |
| Love, RR | 2 |
| Carbone, PP | 2 |
| Verma, AK | 3 |
| Gilmore, D | 1 |
| Carey, P | 1 |
| Tutsch, KD | 2 |
| Pomplun, M | 2 |
| Wilding, G | 1 |
| Löser, C | 1 |
| Starp, F | 1 |
| Fölsch, UR | 1 |
| Emerson, S | 1 |
| Durbin, T | 1 |
| Doyle, K | 1 |
| Lagerberg, W | 1 |
| Douglas, JA | 1 |
| Larson, PO | 1 |
| Blair, IA | 1 |
| Li, H | 1 |
| Schut, HA | 1 |
| Conran, P | 1 |
| Hawk, EE | 1 |
| Kelloff, GJ | 1 |
| Reynolds, S | 1 |
| Rajagopal, S | 1 |
| Chakrabarty, S | 1 |
| Hudmon, KS | 1 |
| Chamberlain, RM | 1 |
| Erdman, SH | 1 |
| Powell, MB | 1 |
| Holubec, H | 1 |
| Guillén-Rodriguez, JM | 1 |
| Viner, JL | 1 |
| Hawk, ET | 1 |
| Yu, D | 1 |
| Seitz, PK | 1 |
| Selvanayagam, P | 1 |
| Rajaraman, S | 1 |
| Townsend, CM | 7 |
| Cooper, CW | 1 |
| Lakanen, JR | 1 |
| Coward, JK | 1 |
| Pegg, AE | 1 |
| Tsunoda, A | 1 |
| Shibusawa, M | 1 |
| Tsunoda, Y | 1 |
| Yasuda, N | 1 |
| Koike, T | 1 |
| Wang, M | 1 |
| Tokumo, K | 2 |
| Rigotty, J | 2 |
| Zang, E | 2 |
| Khoury, MD | 1 |
| Gamet, L | 1 |
| Cazenave, Y | 1 |
| Trocheris, V | 1 |
| Denis-Pouxviel, C | 1 |
| Murat, JC | 1 |
| Zirvi, KA | 1 |
| Atabek, U | 1 |
| Saydjari, R | 6 |
| Alexander, RW | 2 |
| Upp, JR | 2 |
| Barranco, SC | 5 |
| Thompson, JC | 6 |
| Eggstein, S | 1 |
| Imdahl, A | 1 |
| Kohler, M | 1 |
| Waibel, M | 1 |
| Farthmann, EH | 1 |
| Nayini, J | 1 |
| D'Agostino, L | 1 |
| Pignata, S | 1 |
| Daniele, B | 1 |
| D'Adamo, G | 1 |
| Ferraro, C | 1 |
| Silvestro, G | 1 |
| Tagliaferri, P | 1 |
| Contegiacomo, A | 1 |
| Gentile, R | 1 |
| Tritto, G | 1 |
| Neelam, SS | 1 |
| Bernabei, A | 1 |
| Freedland, C | 1 |
| Thompson, R | 1 |
| Corbett, TH | 1 |
| Luk, GD | 4 |
| Zhang, SZ | 2 |
| Hamilton, SR | 2 |
| Celano, P | 3 |
| Baylin, SB | 3 |
| Casero, RA | 3 |
| Halline, AG | 1 |
| Dudeja, PK | 1 |
| Brasitus, TA | 1 |
| Waldrop, RD | 1 |
| Rubin, NH | 1 |
| Rayford, PL | 1 |
| Tempero, MA | 1 |
| Nishioka, K | 2 |
| Knott, K | 1 |
| Zetterman, RK | 1 |
| Umemoto, S | 1 |
| Berchtold, CM | 1 |
| Giardiello, FM | 2 |
| Abeloff, MD | 1 |
| Rosen, ST | 1 |
| Zeltzman, M | 1 |
| Sjoerdsma, A | 1 |
| Tutton, PJ | 1 |
| Barkla, DH | 1 |
| Nelkin, BD | 1 |
| Arundel, CM | 1 |
| Tofilon, PJ | 1 |
| Lamuraglia, GM | 1 |
| Lacaine, F | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients With Familial Adenomatous Polyposis[NCT01483144] | Phase 3 | 171 participants (Actual) | Interventional | 2013-10-31 | Completed | ||
| Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial[NCT00330382] | Phase 2 | 325 participants (Actual) | Interventional | 1999-01-31 | Completed | ||
| TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes[NCT05594563] | Phase 2 | 70 participants (Anticipated) | Interventional | 2023-03-14 | Recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Global assessment of change in lower GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint. (NCT01483144)
Timeframe: through month 12 assessment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Improved | Not Improved | |
| Eflornithine Plus Sulindac | 22 | 34 |
| Eflornithine Plus Sulindac Placebo | 16 | 41 |
| Sulindac Plus Eflornithine Placebo | 22 | 36 |
Global assessment of change in upper GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint. (NCT01483144)
Timeframe: through month 12 assessment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Improved | Not Improved | |
| Eflornithine Plus Sulindac | 11 | 45 |
| Eflornithine Plus Sulindac Placebo | 10 | 47 |
| Sulindac Plus Eflornithine Placebo | 10 | 48 |
Progression of disease by evaluation of FAP-related events over the course of study treatment (NCT01483144)
Timeframe: Up to 48 months from the start of treatment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Number with FAP-related events | Number with Lower GI FAP-related events | |
| Eflornithine Plus Sulindac | 18 | 2 |
| Eflornithine Plus Sulindac Placebo | 23 | 10 |
| Sulindac Plus Eflornithine Placebo | 22 | 9 |
"A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, top photo shows a complete response relative to the bottom photo, through, the same degree of disease is shown by top photo and bottom photo, to bottom photo shows a complete response relative to the top photo. Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo." (NCT00330382)
Timeframe: Baseline to 6 months
| Intervention | score (Mean) |
|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | 4.0 |
| Arm II (Placebo) | 3.6 |
100% x (Posttreatment value - pretreatment value)/(pretreatment value) (NCT00330382)
Timeframe: Baseline to 6 months
| Intervention | percentage change (Median) |
|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | -10.1 |
| Arm II (Placebo) | -4.2 |
100% x (Posttreatment value - pretreatment value)/(pretreatment value) (NCT00330382)
Timeframe: Baseline to 6 months
| Intervention | percentage change (Median) |
|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | 15.7 |
| Arm II (Placebo) | 17.2 |
100% x (Posttreatment value - pretreatment value)/(pretreatment value) (NCT00330382)
Timeframe: Baseline to 6 months
| Intervention | percentage change (Median) |
|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | -3.9 |
| Arm II (Placebo) | -8.1 |
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area. (NCT00330382)
Timeframe: 6 months
| Intervention | percentage change (Mean) |
|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | -20.6 |
| Arm II (Placebo) | -17.1 |
The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period. (NCT00330382)
Timeframe: Baselie to 6 months
| Intervention | score (Mean) |
|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | 1.2 |
| Arm II (Placebo) | 3.6 |
(NCT00330382)
Timeframe: Baseline to 6 months
| Intervention | percentage change (Median) | ||
|---|---|---|---|
| Buccal-Cell New | Protease Activity | Serum Neu (n=41) | |
| Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups | -8.9 | 16.2 | -4.1 |
Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease. (NCT00330382)
Timeframe: 6 months
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Complete response (CR) | Partial response (PR) | Stable disease | Disease progression | |
| Arm I (Bowman-Birk Inhibitor Concentrate) | 2 | 10 | 27 | 4 |
| Arm II (Placebo) | 2 | 12 | 26 | 6 |
The onset of adverse event is between the randomizaiton date and off-study date (NCT00330382)
Timeframe: Randomized date to Off-study date, up to 21 months
| Intervention | participants (Number) | |
|---|---|---|
| Yes: report at least 1 AE | No: no AE reported | |
| Arm I (Bowman-Birk Inhibitor Concentrate) | 33 | 34 |
| Arm II (Placebo) | 25 | 40 |
12 reviews available for eflornithine and Colonic Neoplasms
| Article | Year |
|---|---|
Cancer pharmacoprevention: Targeting polyamine metabolism to manage risk factors for colon cancer.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Chemoprevention; Colonic Neoplasms; Eflornithine; | 2018 |
Nutrition and colon cancer prevention.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Anticarcinogenic Agents; Aspirin; Colonic Neoplasms; Diet; | 2009 |
Studies with the azoxymethane-rat preclinical model for assessing colon tumor development and chemoprevention.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Azoxymethane; Chemoprevention; Colonic Neoplasms; | 2004 |
A comprehensive strategy to combat colon cancer targeting the adenomatous polyposis coli tumor suppressor gene.
Topics: Adenomatous Polyposis Coli Protein; Antineoplastic Agents; Aspirin; Base Sequence; Colonic Neoplasms | 2005 |
Rationale for, and design of, a clinical trial targeting polyamine metabolism for colon cancer chemoprevention.
Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Combined Che | 2007 |
Methylglyoxal-bis(guanylhydrazone) (Methyl-GAG): current status and future prospects.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Chemical Phenomena; Chemistry; Clinical Tri | 1983 |
Chemoprevention of colon cancer by dietary administration of naturally-occurring and related synthetic agents.
Topics: Allyl Compounds; Anethole Trithione; Animals; Anti-Inflammatory Agents, Non-Steroidal; Anticarcinoge | 1997 |
Development of difluoromethylornithine (DFMO) as a chemoprevention agent.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Anticarcinogenic Agents; Cell Division; Cell Trans | 1999 |
Development of difluoromethyl-ornithine and Bowman-Birk inhibitor as chemopreventive agents by assessment of relevant biomarker modulation: some lessons learned.
Topics: Antineoplastic Agents; Biomarkers, Tumor; Colonic Neoplasms; Drug Evaluation; Eflornithine; Humans; | 2001 |
The future of colon cancer prevention.
Topics: Adenocarcinoma; Adenoma; Animals; Anti-Inflammatory Agents, Non-Steroidal; Anticarcinogenic Agents; | 2001 |
Inhibition of tumor promotion by DL-alpha-difluoromethylornithine, a specific irreversible inhibitor of ornithine decarboxylase.
Topics: Animals; Carcinogens; Colonic Neoplasms; Eflornithine; Female; Mammary Neoplasms, Experimental; Mice | 1990 |
Chemoprevention and chemotherapy by inhibition of ornithine decarboxylase activity and polyamine synthesis: colonic, pancreatic, mammary, and renal carcinomas.
Topics: Animals; Antineoplastic Agents; Breast Neoplasms; Cell Division; Colonic Neoplasms; Eflornithine; Fe | 1985 |
8 trials available for eflornithine and Colonic Neoplasms
| Article | Year |
|---|---|
Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trial.
Topics: Adenomatous Polyposis Coli; Adult; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Proto | 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 |
Rationale for, and design of, a clinical trial targeting polyamine metabolism for colon cancer chemoprevention.
Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Combined Che | 2007 |
Methylglyoxal-bis(guanylhydrazone) (Methyl-GAG): current status and future prospects.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Chemical Phenomena; Chemistry; Clinical Tri | 1983 |
Randomized phase I chemoprevention dose-seeking study of alpha-difluoromethylornithine.
Topics: Adult; Carcinoma; Colonic Neoplasms; Eflornithine; Enzyme Induction; Female; Humans; Male; Ornithine | 1993 |
Development of difluoromethylornithine as a chemoprevention agent for the management of colon cancer.
Topics: Anticarcinogenic Agents; Cell Division; Colonic Neoplasms; Dose-Response Relationship, Drug; Eflorni | 1995 |
Effect of alpha-difluoromethylornithine on rectal mucosal levels of polyamines in a randomized, double-blinded trial for colon cancer prevention.
Topics: Adult; Aged; Aged, 80 and over; Anticarcinogenic Agents; Audiometry; Colonic Neoplasms; Double-Blind | 1998 |
Phase I chemoprevention study of piroxicam and alpha-difluoromethylornithine.
Topics: Adult; Aged; Aged, 80 and over; Anticarcinogenic Agents; Biopsy; Breast Neoplasms; Colonic Neoplasms | 1998 |
62 other studies available for eflornithine and Colonic Neoplasms
| 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 |
Metabolomics of adherent mammalian cells by capillary electrophoresis-mass spectrometry: HT-29 cells as case study.
Topics: Adenocarcinoma; Antineoplastic Agents; Cell Adhesion; Cell Proliferation; Colonic Neoplasms; Eflorni | 2015 |
Quilamine HQ1-44, an iron chelator vectorized toward tumor cells by the polyamine transport system, inhibits HCT116 tumor growth without adverse effect.
Topics: Animals; Antineoplastic Agents; Biological Transport; Cell Cycle; Cell Survival; Colonic Neoplasms; | 2015 |
PACES trial: Evaluating the effectiveness of eflornithine and sulindac in preventing colon adenomas.
Topics: Adenoma; Antineoplastic Agents; Clinical Trials as Topic; Colon; Colonic Neoplasms; Eflornithine; Hu | 2015 |
Potentiating NK cell activity by combination of Rosuvastatin and Difluoromethylornithine for effective chemopreventive efficacy against Colon Cancer.
Topics: Adenocarcinoma; Animals; Antineoplastic Agents; beta Catenin; Colonic Neoplasms; Cyclin D1; Disease | 2016 |
Novel cell culture model for prevention of carcinogenic risk in familial adenomatous polyposis syndrome.
Topics: Adenomatous Polyposis Coli; Animals; Anticarcinogenic Agents; Catechin; Cell Line; Colonic Neoplasms | 2009 |
Off-label use of approved drugs.
Topics: Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Colonic Neoplasms; Drug Ap | 2009 |
Polyamine transport is mediated by both endocytic and solute carrier transport mechanisms in the gastrointestinal tract.
Topics: Animals; Biological Transport; Catalysis; Caveolae; Caveolin 1; Cell Line, Tumor; Colonic Neoplasms; | 2010 |
Phospho-sulindac (OXT-328), a novel sulindac derivative, is safe and effective in colon cancer prevention in mice.
Topics: Acetyltransferases; Animals; Antineoplastic Agents; Biogenic Polyamines; Cell Line, Tumor; Colonic N | 2010 |
Phospho-sulindac (OXT-922) inhibits the growth of human colon cancer cell lines: a redox/polyamine-dependent effect.
Topics: Acetyltransferases; Antineoplastic Agents; Apoptosis; Blotting, Western; Cell Cycle; Cell Line, Tumo | 2010 |
Phospho-sulindac (OXT-328) combined with difluoromethylornithine prevents colon cancer in mice.
Topics: Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Apoptosis; Cell Prol | 2011 |
The metabolism and pharmacokinetics of phospho-sulindac (OXT-328) and the effect of difluoromethylornithine.
Topics: Animals; Cell Line, Tumor; Colonic Neoplasms; Cytosol; Eflornithine; Female; Humans; In Vitro Techni | 2012 |
Altered expression of c-myc, p16 and p27 in rat colon tumors and its reversal by short-term treatment with chemopreventive agents.
Topics: Animals; Antineoplastic Agents; Calcium Chloride; Cell Cycle Proteins; Chemoprevention; Colonic Neop | 2002 |
Growth-inhibitory effects of the chemopreventive agent indole-3-carbinol are increased in combination with the polyamine putrescine in the SW480 colon tumour cell line.
Topics: Anticarcinogenic Agents; Antineoplastic Agents; Apoptosis; Biological Transport; Cell Cycle; Cell Di | 2003 |
The chemopreventive agent alpha-difluoromethylornithine blocks Ki-ras-dependent tumor formation and specific gene expression in Caco-2 cells.
Topics: Animals; Antineoplastic Agents; Caco-2 Cells; Cell Communication; Cell Movement; Colonic Neoplasms; | 2004 |
Modulation by celecoxib and difluoromethylornithine of the methylation of DNA and the estrogen receptor-alpha gene in rat colon tumors.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Azoxymethane; Biomarkers, Tumor; Carcinogen | 2004 |
Ornithine decarboxylase, mitogen-activated protein kinase and matrix metalloproteinase-2 expressions in human colon tumors.
Topics: Antineoplastic Agents; Colonic Neoplasms; Eflornithine; Humans; Matrix Metalloproteinase 2; Mitogen- | 2005 |
Impact of dietary amino acids and polyamines on intestinal carcinogenesis and chemoprevention in mouse models.
Topics: Amino Acids; Animals; Anticarcinogenic Agents; Antineoplastic Agents; Colonic Neoplasms; Diet; Disea | 2007 |
Follow-up of tumor development in the colons of living rats and implications for chemoprevention trials: assessment of aspirin-difluoromethylornithine combination.
Topics: 1,2-Dimethylhydrazine; Animals; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Aspi | 2007 |
Drugs to prevent colon cancer show promise, but hurdles remain for chemoprevention.
Topics: Adenoma; Animals; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Combined Chemotherapy Prot | 2008 |
Inhibition of ornithine decarboxylase with 2-difluoromethylornithine: reduced incidence of dimethylhydrazine-induced colon tumors in mice.
Topics: 1,2-Dimethylhydrazine; Animals; Carboxy-Lyases; Carcinogens; Cell Survival; Colonic Neoplasms; Dimet | 1983 |
Regional chemoprevention of carcinogen-induced tumors in rat colon.
Topics: Animals; Anticarcinogenic Agents; Azoxymethane; Colonic Neoplasms; Eflornithine; Ellagic Acid; Male; | 1995 |
Polyamine-dependent expression of the matrix metalloproteinase matrilysin in a human colon cancer-derived cell line.
Topics: Adenocarcinoma; Antibody Specificity; Biogenic Polyamines; Blotting, Western; Cell Division; Colonic | 1994 |
Modulation of azoxymethane-induced mutational activation of ras protooncogenes by chemopreventive agents in colon carcinogenesis.
Topics: Animals; Anticarcinogenic Agents; Azoxymethane; Base Sequence; Colon; Colonic Neoplasms; Eflornithin | 1994 |
Selenium and difluoromethylornithine additively inhibit DMH-induced distal colon tumor formation in rats fed a fiber-free diet.
Topics: 1,2-Dimethylhydrazine; Animals; Carcinogens; Colon; Colonic Neoplasms; Diet; Dietary Fiber; Dimethyl | 1993 |
Effects of gastrin and difluoromethylornithine on growth of human colon cancer.
Topics: Animals; Colonic Neoplasms; Eflornithine; Humans; In Vitro Techniques; Mice; Mice, Nude; Neoplasm Tr | 1993 |
Intermediate biomarkers of colon cancer: modulation of expression of ras oncogene by chemopreventive agents during azoxymethane induced colon carcinogenesis.
Topics: Affinity Labels; Animals; Azoxymethane; Biomarkers, Tumor; Blotting, Western; Colonic Neoplasms; Efl | 1993 |
Dissimilar activation patterns of the carcinogen dimethylhydrazine (DMH) on intracellular polyamine metabolism in various organs.
Topics: 1,2-Dimethylhydrazine; Acetyltransferases; Adenosylmethionine Decarboxylase; Animals; Carcinogens; C | 1996 |
Growth arrest- and polyamine-dependent expression of spermidine/spermine N1-acetyltransferase in human tumor cells.
Topics: Acetyltransferases; Blotting, Northern; Cell Division; Colonic Neoplasms; Dactinomycin; Eflornithine | 1996 |
Prevention by aspirin and its combination with alpha-difluoromethylornithine of azoxymethane-induced tumors, aberrant crypt foci and prostaglandin E2 levels in rat colon.
Topics: Animals; Aspirin; Azoxymethane; Colon; Colonic Neoplasms; Dinoprostone; Dose-Response Relationship, | 1999 |
Differentiation-inducing effect of retinoic acid, difluoromethylornithine, sodium butyrate and sodium suramin in human colon cancer cells.
Topics: Antineoplastic Agents; Butyrates; Carcinoembryonic Antigen; Cell Differentiation; Cell Division; Col | 1998 |
Perceived benefits of and barriers to participation in a phase I/II colon cancer chemoprevention trial.
Topics: Adult; Aged; Anticarcinogenic Agents; Chemoprevention; Clinical Trials as Topic; Clinical Trials, Ph | 1999 |
APC-dependent changes in expression of genes influencing polyamine metabolism, and consequences for gastrointestinal carcinogenesis, in the Min mouse.
Topics: Acetyltransferases; Animals; Anticarcinogenic Agents; Colon; Colonic Neoplasms; Eflornithine; Gene E | 1999 |
Effects of vasoactive intestinal peptide on adenosine 3',5'-monophosphate, ornithine decarboxylase, and cell growth in a human colon cell line.
Topics: Adenocarcinoma; Blotting, Northern; Cell Division; Cell Line; Colonic Neoplasms; Cyclic AMP; Dose-Re | 1992 |
alpha-Methyl polyamines: metabolically stable spermidine and spermine mimics capable of supporting growth in cells depleted of polyamines.
Topics: Animals; Cell Division; Cell Line, Transformed; Colonic Neoplasms; Eflornithine; Humans; Leukemia L1 | 1992 |
Reduced growth rate of dimethylhydrazine-induced colon tumors in rats.
Topics: Animals; Body Weight; Cell Division; Colonic Neoplasms; Dimethylhydrazines; Eflornithine; Male; Mito | 1992 |
[Inhibition by polyamine biosynthesis inhibitor DFMO of the growth of transplanted human colon cancer in nude mice].
Topics: Animals; Bone Marrow; Cecal Neoplasms; Colonic Neoplasms; Eflornithine; Humans; Mice; Mice, Inbred B | 1991 |
Chemoprevention of colon carcinogenesis by dietary administration of piroxicam, alpha-difluoromethylornithine, 16 alpha-fluoro-5-androsten-17-one, and ellagic acid individually and in combination.
Topics: Animals; Body Weight; Colonic Neoplasms; Dehydroepiandrosterone; Drug Combinations; Drug Evaluation, | 1991 |
Prevention by chemopreventive agents of azoxymethane-induced foci of aberrant crypts in rat colon.
Topics: Acetylcysteine; Allyl Compounds; Animals; Anticarcinogenic Agents; Azoxymethane; Colon; Colonic Neop | 1991 |
Involvement of ornithine decarboxylase in the control of proliferation of the HT29 human colon cancer cell line. Effect of vasoactive intestinal peptide on enzyme activity.
Topics: Cell Division; Colonic Neoplasms; Cyclic AMP; Eflornithine; Fetal Blood; Humans; Ornithine Decarboxy | 1991 |
In vitro response of a human colon tumor xenograft and a lung adenocarcinoma cell line to alpha-difluoromethylornithine alone and in combination with 5-fluorouracil and doxorubicin.
Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Cell Division; Colonic Neoplasms; Do | 1991 |
Differential sensitivity of various human tumors to inhibition of polyamine biosynthesis in vivo.
Topics: Adenocarcinoma; Animals; Cell Line; Colonic Neoplasms; Eflornithine; Humans; Mice; Mice, Inbred BALB | 1991 |
Influence of gastrin, gastrin receptor blockers, epidermal growth factor, and difluoromethylornithine on the growth and the activity of ornithine decarboxylase of colonic carcinoma cells.
Topics: Animals; Anti-Ulcer Agents; Benzamides; Cell Division; Colonic Neoplasms; Eflornithine; Epidermal Gr | 1991 |
Chemoprevention of colon carcinogenesis by concurrent administration of piroxicam, a nonsteroidal antiinflammatory drug with D,L-alpha-difluoromethylornithine, an ornithine decarboxylase inhibitor, in diet.
Topics: Adenocarcinoma; Animals; Antineoplastic Combined Chemotherapy Protocols; Body Weight; Colonic Neopla | 1990 |
Polyamine uptake by human colon carcinoma cell line CaCo-2.
Topics: Biogenic Polyamines; Cell Line; Colonic Neoplasms; Eflornithine; Humans; Ornithine Decarboxylase; Or | 1990 |
Combination of flavone acetic acid (FAA) with adriamycin, cis-platinum and difluoromethylornithine (DFMO) in vitro against human colon cancer cells.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Cell Division; Cisplatin; Col | 1990 |
Effects of timing of administration and dose of difluoromethylornithine on rat colonic carcinogenesis.
Topics: Animals; Azoxymethane; Colon; Colonic Neoplasms; Eflornithine; Enzyme Induction; Intestinal Mucosa; | 1989 |
Polyamines differentially modulate the transcription of growth-associated genes in human colon carcinoma cells.
Topics: Actins; Cell Division; Cell Line; Colonic Neoplasms; Eflornithine; Genes; Histones; Humans; Ornithin | 1989 |
1,2-Dimethylhydrazine-induced alterations in N1-acetylspermidine levels in rat distal colonic mucosa: effects of 2-difluoromethylornithine.
Topics: 1,2-Dimethylhydrazine; Acetyltransferases; Adenosylmethionine Decarboxylase; Animals; Chromatography | 1989 |
Photoperiod influences the growth of colon cancer in mice.
Topics: Adenocarcinoma; Animals; Body Weight; Circadian Rhythm; Colonic Neoplasms; Eflornithine; Light; Male | 1989 |
Chemoprevention of mouse colon tumors with difluoromethylornithine during and after carcinogen treatment.
Topics: Animals; Colonic Neoplasms; Dimethylhydrazines; Eflornithine; Erythrocytes; Male; Mice; Polyamines; | 1989 |
2-Deoxy-D-glucose inhibits the antitumor effects of alpha-difluoromethylornithine on the growth of colon cancer in vivo.
Topics: Animals; Biogenic Polyamines; Cell Survival; Colonic Neoplasms; Deoxy Sugars; Deoxyglucose; DNA, Neo | 1989 |
[Antitumor effect of alpha-difluoromethylornithine (DFMO) changes in ornithine decarboxylase (ODC) activity and polyamine (PA) levels in human tumor transplanted into nude mice].
Topics: Animals; Biogenic Polyamines; Breast Neoplasms; Colonic Neoplasms; Drug Screening Assays, Antitumor; | 1989 |
Modulation of growth gene expression by selective alteration of polyamines in human colon carcinoma cells.
Topics: Adenosine; Blotting, Northern; Cell Division; Cell Line; Colonic Neoplasms; Eflornithine; Gene Expre | 1989 |
Phase II trials of alpha-difluoromethylornithine, an inhibitor of polyamine synthesis, in advanced small cell lung cancer and colon cancer.
Topics: Aged; Antineoplastic Agents; Carcinoma, Small Cell; Colonic Neoplasms; Drug Evaluation; Eflornithine | 1986 |
Comparison of the effects of an ornithine decarboxylase inhibitor on the intestinal epithelium and on intestinal tumors.
Topics: Animals; Cell Division; Colonic Neoplasms; Eflornithine; Epithelium; Female; Intestines; Male; Mice; | 1986 |
Effects of cyclosporine and alpha-difluoromethylornithine on the growth of mouse colon cancer in vitro.
Topics: Adenocarcinoma; Animals; Cell Division; Colonic Neoplasms; Cyclosporins; Eflornithine; In Vitro Tech | 1987 |
Cyclosporine and alpha-difluoromethylornithine exhibit differential effects on colon and pancreatic cancer in vitro.
Topics: Animals; Colonic Neoplasms; Cyclosporins; Dose-Response Relationship, Drug; Eflornithine; Humans; Mi | 1987 |
Effect of polyamine depletion on c-myc expression in human colon carcinoma cells.
Topics: Actins; Cell Cycle; Cell Division; Colonic Neoplasms; Dactinomycin; Eflornithine; Gene Expression Re | 1988 |
Effects of alpha-difluoromethylornithine-induced polyamine depletion on the radiosensitivity of a human colon carcinoma cell line.
Topics: Cell Line; Cell Survival; Cesium Radioisotopes; Colonic Neoplasms; Eflornithine; Gamma Rays; Humans; | 1988 |
Alpha-difluoromethylornithine-induced inhibition of growth of autochthonous experimental colonic tumors produced by azoxymethane in male F344 rats.
Topics: Animals; Azoxymethane; Colonic Neoplasms; Eflornithine; Male; Ornithine Decarboxylase; Rats; Rats, I | 1988 |
Differential sensitivity of pancreatic and colon cancer to cyclosporine and alpha-difluoromethylornithine in vivo.
Topics: Adenocarcinoma; Animals; Colonic Neoplasms; Cricetinae; Cyclosporins; Eflornithine; Mesocricetus; Mi | 1988 |