Phase II Clinical Trial of AZD2171 Monotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Patients
I. Determine the objective clinical response in patients with recurrent or newly diagnosed
metastatic squamous cell carcinoma of the head and neck treated with AZD2171 (cediranib
I. Determine the safety profile of this drug in these patients. II. Assess the early and
late physiological and biological effects of this drug on tumor interstitial fluid pressure,
pO2, and tumor microvasculature.
III. Assess the value of potential noninvasive biomarkers of response, including plasma
levels of molecules involved in angiogenesis, circulating endothelial cells and progenitor
cells, and functional imaging changes before and after treatment.
IV. Assess the gene expression patterns before and after treatment as predictors of clinical
and biological response.
OUTLINE: This is a multicenter study.
Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced CT imaging and blood collection periodically
during study for research studies assessing plasma levels of angiogenic/antiangiogenic
molecules, circulating endothelial cells (by flow cytometry), progenitor cells, and protein
analysis of potential biomarkers.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response (complete response [CR], partial response [PR], progressive disease [PD], and stable disease [SD]) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Compared using logistic regression.
Baseline to day 29
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|