Trial Information

A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma

This is a comprehensive study that uses a novel agent that targets angiogenesis
(bevacizumab) in combination with conventional chemotherapy for the treatment of
osteosarcoma. Bevacizumab, a monoclonal antibody against the vascular endothelial growth
factor (VEGF), has been shown to stop the growth of new blood vessels of tumors, both in the
laboratory and in patients with other types of cancers. Bevacizumab has improved the effect
of chemotherapy in adult patients with different types of cancer by increasing tumor
response and increasing the chances of survival. This study has two main goals:

- To find out if bevacizumab can be combined safely with chemotherapy for osteosarcoma

- To find out if adding bevacizumab to chemotherapy will be beneficial in treating
osteosarcoma.

The chemotherapy drugs used in this study are commonly used to treat osteosarcoma. Patients
with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of
cisplatin, doxorubicin and high-dose methotrexate. Patients with metastatic tumors or tumors
that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of
cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. If the tumor
can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will
be followed by additional chemotherapy. After completion of active therapy, patient's
response to therapy will be followed for approximately 5 years.