Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma
I. Determine the objective response rate in patients with malignant pleural, peritoneal, or
tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with
AZD2171 (cediranib maleate).
I. Determine the progression-free survival of patients treated with AZD2171. II. Determine
the toxicity experienced by patients treated with AZD2171. III. Determine median and overall
survival of patients treated with AZD2171.
I. Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum
biomarkers of angiogenesis as predictive or prognostic markers for future investigations of
this drug in malignant mesothelioma.
OUTLINE: This is a multicenter study.
Patients receive oral cediranib maleate once daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity. Patients undergo blood
collection periodically during study for biomarker and optional pharmacogenomic correlative
studies. After completion of study treatment, patients are followed for up to 8 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete or partial response [CR or PR]) of patients with malignant mesothelioma who are treated with cediranib maleate
Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
Every 8 weeks
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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