A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer (ECOG E1305)

Conditions

Head and Neck Cancer | Larynx | Lip, Oral Cavity and Pharynx

What is the purpose of this trial?

The purpose of this study is to compare the effects (good and bad) of the addition of a drug called bevacizumab to the standard chemotherapy to see which works better. We will determine if the combination of standard chemotherapy (cisplatin and docetaxel, cisplatin and 5-FU, carboplatin and docetaxel, or carboplatin and 5-FU) and bevacizumab can increase the effectiveness of treatment for head and neck cancer. This combination is experimental. We will determine if adding bevacizumab to standard therapy produces results that are better than those we would ordinarily expect. Currently, we do not know whether using bevacizumab will be effective. This is a subject of this study. Bevacizumab is approved by the Food and Drug Administration (FDA) for another type of cancer, colorectal cancer, but is not approved for head and neck cancer. Bevacizumab is a monoclonal antibody (antibodies which are clones of a single parent cell) that is directed against a substance called vascular endothelial growth factor, or VEGF. VEGF helps blood vessels grow, and cancer cells produce too much of it. Bevacizumab stops the growth of blood vessels that feed the tumor. In other words, it can starve the tumor and prevent it from growing. Bevacizumab has been shown to enhance the effect of chemotherapy against cancer in some other cancer types.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Eastern Cooperative Oncology Group
Dates:
08/25/2011
Last Updated:
Study HIC#:
1103008120