A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

Phase 2 Completed 43 enrolled St. Jude Children's Research Hospital Genentech, Inc. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). Chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.

Timeline

Start: 2008-06-03
Primary completion: 2014-08
Completion: 2017-08

Publications

Turner DC, Navid F, Daw NC, Mao S, Wu J, Santana VM, Neel M, Rao B, Willert JR, Loeb DM, Harstead KE, Throm SL, Freeman BB 3rd, Stewart CF. Population pharmacokinetics of bevacizumab in children with osteosarcoma: implications for dosing. Clin Cancer Res. 2014 May 15;20(10):2783-92. doi: 10.1158/1078-0432.CCR-13-2364. Epub 2014 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Cisplatin	Other / unclassified	—	Intravenous
Background	Doxorubicin	Other / unclassified	—	Intravenous
Background	Etoposide	Small molecule	—	Intravenous
Background	Ifosfamide	Small molecule	—	Intravenous
Background	Methotrexate	Small molecule	—	Intravenous

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

Summary

Timeline

Publications

Drugs

Indications