Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
A Phase II Study of Sunitinib (SU11248; NSC 736511) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors.
PRIMARY OBJECTIVES:
I. To assess the efficacy (response rate) of sunitinib (sunitinib malate) given orally daily
in patients with advanced or metastatic previously treated epithelial ovarian, fallopian
tube, or primary peritoneal carcinoma.
II. To assess the toxicity of sunitinib in patients with advanced or metastatic previously
treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
III. To document cancer antigen 125 (CA125) response rate, early objective progression rate,
and, if objective responses are observed, response duration.
OUTLINE:
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up 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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