Tongue Cancer Clinical Trial
Official title:
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
This phase II trial is studying how well giving cetuximab together with bevacizumab works in treating patients with recurrent or metastatic head and neck cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Giving cetuximab together with bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with recurrent or metastatic squamous
cell carcinoma of the head and neck treated with cetuximab and bevacizumab.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with this
regimen.
II. Determine the levels of soluble epidermal growth factor receptor (EGFR) in blood samples
before and after dual EGFR and vascular endothelial growth factor inhibition.
III. Evaluate treatment-related toxicities of this regimen in these patients. IV. Collect
and bank blood samples for future correlative studies.
OUTLINE: This is a multicenter study. Patients receive cetuximab intravenously (IV) over 1-2
hours on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats
every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected at baseline to determine whether biomarkers on tumor
tissue and/or blood can be linked with clinical response and to measure signaling pathways
by reverse phase protein microarray. Epidermal growth factor receptor (EGFR) gene copy
number is assessed by fluorescent in situ hybridization (FISH) on tumor tissue pretreatment.
Blood samples are also collected at baseline and on day 21 of course 1 for analysis by
acridinium-linked immunosorbent assay (ALISA) to quantify serum p110 sEGFR protein levels.
After completion of study treatment, patients are followed every 2-3 months for 2 years and
then every 6 months for 3 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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