Endometrial Adenocarcinoma Clinical Trial
Official title:
A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma
This phase II trial studies how well sunitinib malate works in treating patients with endometrial cancer that has come back after a period of improvement (recurrent) or has spread to other places in the body (metastatic). Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To assess the objective response rate of recurrent or metastatic endometrial cancer to
sunitinib (sunitinib malate).
II. To assess the frequency of prolonged stable disease (as defined by percentage [%] of
patients alive and free from progressive disease at 6 months) in patients with recurrent or
metastatic endometrial cancer treated with sunitinib.
SECONDARY OBJECTIVES:
I. To assess time-to- progression, median overall survival, and rate of one-year survival in
patients with recurrent or metastatic endometrial cancer treated with sunitinib.
II. To assess the toxicity associated with sunitinib in patients with recurrent or metastatic
endometrial cancer.
OUTLINE:
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat
every 6 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 4 weeks and then every 3
months until relapse.
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