A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
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.
I. Determine the progression-free and overall survival of patients treated with this
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
Objective response rate with the combination of cetuximab and bevacizumab in recurrent or metastatic head and neck cancer
Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The 95% confidence intervals should be provided.
Baseline and every 3 weeks if using physical exam or plain x-ray or every 6 weeks if using CT scan or MRI
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Case Western Reserve University||Cleveland, Ohio 44106|
|M D Anderson Cancer Center||Houston, Texas 77030|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|