Recurrent Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma
This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.
PRIMARY OBJECTIVES:
I. Assess the efficacy of sunitinib malate, in terms of response rate (complete and
partial), in patients with malignant pleural mesothelioma.
II. Assess the toxicity, safety, and tolerability of this drug in these patients.
III. Assess the duration of response or stable disease, stable disease rate,
progression-free survival, and median and overall survival rates.
OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified
according to prior cytotoxic chemotherapy (yes vs no).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6
weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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