Literature DB >> 20960192

A prospective phase II study of 2-methoxyestradiol administered in combination with bevacizumab in patients with metastatic carcinoid tumors.

Matthew H Kulke1, Jennifer A Chan, Jeffrey A Meyerhardt, Andrew X Zhu, Thomas A Abrams, Lawrence S Blaszkowsky, Eileen Regan, Carolyn Sidor, Charles S Fuchs.   

Abstract

PURPOSE: Angiogenesis inhibition has emerged as a potentially promising treatment strategy for neuroendocrine tumors. 2-Methoxyestradiol (2ME2; Panzem(®)) is a natural derivative of estradiol with demonstrated anti-angiogenic activity in animal models. We performed a prospective, phase II study of 2ME2, administered in combination with bevacizumab, in patients with advanced carcinoid tumors.
METHODS: Thirty-one patients with advanced carcinoid tumors were treated with 2ME2, administered orally at a dose of 1,000 mg four times daily. Patients also received bevacizumab 5 mg/kg intravenously every 2 weeks. Patients were observed for evidence of toxicity, tumor response, and survival.
RESULTS: The combination of 2ME2 and bevacizumab was relatively easily tolerated and was associated with anticipated toxicities for these two agents. No confirmed radiologic responses (by RECIST) were observed. However, 68% of the radiologically evaluable patients experienced at least some degree of tumor reduction, and the median progression-free survival (PFS) time was 11.3 months.
CONCLUSION: 2ME2 and bevacizumab can be safely administered to patients with advanced carcinoid tumors. While major tumor regression was not observed with this regimen, the encouraging median progression-free survival time suggests that this regimen has some degree of antitumor activity and supports the further investigation of angiogenesis inhibitors in this disease.

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Year:  2010        PMID: 20960192      PMCID: PMC3955980          DOI: 10.1007/s00280-010-1478-7

Source DB:  PubMed          Journal:  Cancer Chemother Pharmacol        ISSN: 0344-5704            Impact factor:   3.333


  23 in total

1.  Phase II study of recombinant human endostatin in patients with advanced neuroendocrine tumors.

Authors:  Matthew H Kulke; Emily K Bergsland; David P Ryan; Peter C Enzinger; Thomas J Lynch; Andrew X Zhu; Jeffrey A Meyerhardt; John V Heymach; William E Fogler; Carolyn Sidor; Ann Michelini; Kate Kinsella; Alan P Venook; Charles S Fuchs
Journal:  J Clin Oncol       Date:  2006-08-01       Impact factor: 44.544

2.  Expression of vascular endothelial growth factor in digestive neuroendocrine tumours.

Authors:  B Terris; J Y Scoazec; L Rubbia; L Bregeaud; M S Pepper; P Ruszniewski; J Belghiti; J Fléjou; C Degott
Journal:  Histopathology       Date:  1998-02       Impact factor: 5.087

3.  A phase II multicenter, randomized, double-blind, safety trial assessing the pharmacokinetics, pharmacodynamics, and efficacy of oral 2-methoxyestradiol capsules in hormone-refractory prostate cancer.

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Journal:  Clin Cancer Res       Date:  2005-09-15       Impact factor: 12.531

4.  Potent antitumor activity of 2-methoxyestradiol in human pancreatic cancer cell lines.

Authors:  G Schumacher; M Kataoka; J A Roth; T Mukhopadhyay
Journal:  Clin Cancer Res       Date:  1999-03       Impact factor: 12.531

5.  Phase I clinical trial of oral 2-methoxyestradiol, an antiangiogenic and apoptotic agent, in patients with solid tumors.

Authors:  William L Dahut; Nehal J Lakhani; James L Gulley; Philip M Arlen; Elise C Kohn; Herbert Kotz; Debbie McNally; Allyson Parr; Diana Nguyen; Sherry X Yang; Seth M Steinberg; Jürgen Venitz; Alex Sparreboom; William D Figg
Journal:  Cancer Biol Ther       Date:  2006-01-22       Impact factor: 4.742

6.  2-Methoxyestradiol and analogs as novel antiproliferative agents: analysis of three-dimensional quantitative structure-activity relationships for DNA synthesis inhibition and estrogen receptor binding.

Authors:  Richard A Hughes; Trudi Harris; Emile Altmann; David McAllister; Ross Vlahos; Alan Robertson; Mark Cushman; Zhiqiang Wang; Alastair G Stewart
Journal:  Mol Pharmacol       Date:  2002-05       Impact factor: 4.436

7.  Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.

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Journal:  J Clin Oncol       Date:  2009-08-24       Impact factor: 44.544

8.  The endogenous oestrogen metabolite 2-methoxyoestradiol inhibits angiogenesis and suppresses tumour growth.

Authors:  T Fotsis; Y Zhang; M S Pepper; H Adlercreutz; R Montesano; P P Nawroth; L Schweigerer
Journal:  Nature       Date:  1994-03-17       Impact factor: 49.962

9.  Streptozocin-doxorubicin, streptozocin-fluorouracil or chlorozotocin in the treatment of advanced islet-cell carcinoma.

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10.  A phase II clinical and pharmacodynamic study of temsirolimus in advanced neuroendocrine carcinomas.

Authors:  I Duran; J Kortmansky; D Singh; H Hirte; W Kocha; G Goss; L Le; A Oza; T Nicklee; J Ho; D Birle; G R Pond; D Arboine; J Dancey; S Aviel-Ronen; M-S Tsao; D Hedley; L L Siu
Journal:  Br J Cancer       Date:  2006-10-10       Impact factor: 7.640

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  32 in total

1.  Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors.

Authors:  Jennifer A Chan; Keith Stuart; Craig C Earle; Jeffrey W Clark; Pankaj Bhargava; Rebecca Miksad; Lawrence Blaszkowsky; Peter C Enzinger; Jeffrey A Meyerhardt; Hui Zheng; Charles S Fuchs; Matthew H Kulke
Journal:  J Clin Oncol       Date:  2012-07-09       Impact factor: 44.544

Review 2.  Predictive Markers of Response to Everolimus and Sunitinib in Neuroendocrine Tumors.

Authors:  Diana Martins; Francesca Spada; Ioana Lambrescu; Manila Rubino; Chiara Cella; Bianca Gibelli; Chiara Grana; Dario Ribero; Emilio Bertani; Davide Ravizza; Guido Bonomo; Luigi Funicelli; Eleonora Pisa; Dario Zerini; Nicola Fazio
Journal:  Target Oncol       Date:  2017-10       Impact factor: 4.493

Review 3.  Relevance of angiogenesis in neuroendocrine tumors.

Authors:  Alexandre Teulé; Oriol Casanovas
Journal:  Target Oncol       Date:  2012-05-17       Impact factor: 4.493

4.  Pharmacologic effects of 2-methoxyestradiol on angiotensin type 1 receptor down-regulation in rat liver epithelial and aortic smooth muscle cells.

Authors:  Sivaramakrishna Koganti; Russell Snyder; Thomas Thekkumkara
Journal:  Gend Med       Date:  2012-02-25

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7.  Neuronal Nitric Oxide Synthase-Mediated Genotoxicity of 2-Methoxyestradiol in Hippocampal HT22 Cell Line.

Authors:  Magdalena Gorska; Michal A Zmijewski; Alicja Kuban-Jankowska; Maciej Wnuk; Iwona Rzeszutek; Michal Wozniak
Journal:  Mol Neurobiol       Date:  2015-09-17       Impact factor: 5.590

Review 8.  Alternate Endpoints for Phase II Trials in Advanced Neuroendocrine Tumors.

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Journal:  Oncologist       Date:  2018-08-02

Review 9.  Management of gastric polyps: an endoscopy-based approach.

Authors:  Yasser H Shaib; Massimo Rugge; David Y Graham; Robert M Genta
Journal:  Clin Gastroenterol Hepatol       Date:  2013-04-10       Impact factor: 11.382

Review 10.  Systemic Therapies for Advanced Pancreatic Neuroendocrine Tumors.

Authors:  Nitya Raj; Diane Reidy-Lagunes
Journal:  Hematol Oncol Clin North Am       Date:  2015-10-23       Impact factor: 3.722

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