Evaluating the addition of AMG 655 to mFOLFOX6/bevacizumab in metastatic colorectal cancer Journal Article

  


Authors: Fuchs, C. S.; Saltz, L. B.
Article Title: Evaluating the addition of AMG 655 to mFOLFOX6/bevacizumab in metastatic colorectal cancer
Abstract: Fluoropyrimidine-based chemotherapy has been the mainstay of treatment of advanced colorectal cancer (CRC) for over 4 decades. More recently, the addition of bevacizumab to fluorouracil-based combination chemotherapy has resulted in clinically meaningful improvement in survival in patients with metastatic disease. Still, there remains an urgent unmet need for potentially more effective treatment options. AMG 655 is an investigational fully human monoclonal agonist antibody in the early stages of development by Amgen as a potential therapy for several types of cancer. AMG 655 targets death receptor 5 (DR5), a cell-surface receptor that induces apoptosis. Amgen study 20060464 (ClinicalTrials.gov identifier NCT00625651) is a phase Ib/II study of AMG 655 in combination with modified (m) FOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) and bevacizumab as first-line therapy of metastatic CRC. The first part of this trial, already completed, is an open-label dose-escalation study designed to determine the safety, tolerability, and maximum tolerated dose of AMG 655 when combined with mFOLFOX6/bevacizumab. The second part is a multicenter, randomized, double-blinded, placebo-controlled three-arm trial designed to evaluate the efficacy of two different AMG 655 doses in combination with mFOLFOX6/bevacizumab compared with mFOLFOX6/bevacizumab alone. This part is now actively enrolling patients. Its primary endpoint is progression-free survival. © 2008 Elsevier Inc. All rights reserved.
Keywords: cancer survival; unclassified drug; clinical trial; drug tolerability; fatigue; bevacizumab; fluorouracil; placebo; cancer combination chemotherapy; drug safety; nonhuman; patient selection; side effect; gemcitabine; pancreas cancer; drug megadose; colorectal cancer; metastasis; apoptosis; multiple cycle treatment; high risk patient; irinotecan; monoclonal antibody; chill; drug dose escalation; fever; hypomagnesemia; cancer regression; drug uptake; folinic acid; death receptor 5; tumor necrosis factor related apoptosis inducing ligand; short survey; maximum tolerated dose; oxaliplatin; triacylglycerol lipase blood level; amg 655
Journal Title: Community Oncology
Volume: 5
Issue: 10 Suppl. A
ISSN: 1548-5315
Publisher: Elsevier Inc.  
Date Published: 2008-10-01
Start Page: 1
End Page: 4
Language: English
PROVIDER: scopus
DOI/URL:

http://www.scopus.com/inward/record.url?eid=2-s2.0-56149104587&partnerID=40&md5=3fa0aa55da0b0d45e66574c7e98d8b69
Notes: --- - "Cited By (since 1996): 1" - "Export Date: 17 November 2011" - "Source: Scopus"