Journal ArticleDOI
Phase I Safety and Pharmacokinetic Study of Recombinant Human Anti-Vascular Endothelial Growth Factor in Patients With Advanced Cancer
Michael S. Gordon,Kim Margolin,M. Talpaz,George W. Sledge,E. Holmgren,R. Benjamin,Susan Stalter,S. Shak,Daniel C. Adelman +8 more
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TLDR
Multiple doses of rhuMAb VEGF were well tolerated, and pharmacokinetic studies indicate that doses of > or = 0.3 mg/kg have a half-life similar to that of other humanized antibodies.Abstract:
PURPOSE: We investigated the safety and pharmacokinetics of a recombinant human monoclonal antibody to vascular endothelial growth factor (rhuMAb VEGF) in patients with cancer. PATIENTS AND METHODS: Cohorts of patients with metastatic cancer having failed prior therapy entered a phase I trial of rhuMAb VEGF administered by a 90-minute intravenous infusion at doses from 0.1 to 10.0 mg/kg on days 0, 28, 35, and 42. Patients underwent pharmacokinetic sampling on day 0 and had serum samples obtained during the subsequent 28 days. Response assessment was carried out on days 49 and 72. RESULTS: Twenty-five patients with a median Eastern Cooperative Oncology Group performance status of 0 were accrued. There were no grade III or IV adverse events definitely related to the antibody. There were three episodes of tumor-related bleeding. Infusions of rhuMAb VEGF were well tolerated without significant toxicity. Grades I and II adverse events possibly or probably related to study drug included asthenia, headache, and ...read more
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A Randomized Trial of Bevacizumab, an Anti–Vascular Endothelial Growth Factor Antibody, for Metastatic Renal Cancer
James Chih-Hsin Yang,Leah R. Haworth,Richard M. Sherry,Patrick Hwu,Douglas J. Schwartzentruber,Suzanne L. Topalian,Seth M. Steinberg,Helen X. Chen,Steven A. Rosenberg +8 more
TL;DR: Bvacizumab can significantly prolong the time to progression of disease in patients with metastatic renal-cell cancer, and this trial was stopped after the interim analysis met the criteria for early stopping.
Journal ArticleDOI
Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer
TL;DR: The recent approval of bevacizumab by the US FDA as a first-line therapy for metastatic colorectal cancer validates the ideas that VEGF is a key mediator of tumour angiogenesis and that blockingAngiogenesis is an effective strategy to treat human cancer.
Journal ArticleDOI
Bevacizumab in Combination With Oxaliplatin, Fluorouracil, and Leucovorin (FOLFOX4) for Previously Treated Metastatic Colorectal Cancer: Results From the Eastern Cooperative Oncology Group Study E3200
Bruce J. Giantonio,Paul J. Catalano,Neal J. Meropol,Peter J. O'Dwyer,Edith P. Mitchell,Steven R. Alberts,Michael A. Schwartz,Al B. Benson +7 more
TL;DR: The addition of bevacizumab to oxaliplatin, fluorouracil, and leucovorin improves survival duration for patients with previously treated metastatic colorectal cancer.
Journal ArticleDOI
Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
David H. Johnson,Louis Fehrenbacher,William Novotny,Roy S. Herbst,John Nemunaitis,David M. Jablons,Corey J. Langer,Russell F. DeVore,Jacques Gaudreault,Lisa A. Damico,Eric Holmgren,Fairooz F. Kabbinavar +11 more
TL;DR: Bvacizumab in combination with carboplatin and paclitaxel improved overall response and time to progression in patients with advanced or recurrent non-small-cell lung cancer.
Journal ArticleDOI
Phase II, Randomized Trial Comparing Bevacizumab Plus Fluorouracil (FU)/Leucovorin (LV) With FU/LV Alone in Patients With Metastatic Colorectal Cancer
Fairooz F. Kabbinavar,Herbert Hurwitz,Louis Fehrenbacher,Neal J. Meropol,William Novotny,Grazyna Lieberman,Susan Griffing,Emily K. Bergsland +7 more
TL;DR: The encouraging results of this randomized trial support further study of bevacizumab 5 mg/kg plus chemotherapy as first-line therapy for metastatic colorectal cancer.
References
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Clinical evidence of angiogenesis after arterial gene transfer of phVEGF165 in patient with ischaemic limb
Jeffrey M. Isner,Ann Pieczek,Robert M. Schainfeld,Richard Blair,Laura Haley,Takayuki Asahara,Kenneth Rosenfield,Syed Razvi,Kenneth Walsh,James F. Symes +9 more
TL;DR: Administration of endothelial cell mitogens promotes angiogenesis in patients with limb ischaemia and intra-arterial gene transfer of a plasmid which encodes for vascular endothelial growth factor can improve blood supply to the ischaemic limb.