Recurrent Uterine Corpus Sarcoma Clinical Trial
Official title:
A Phase II Evaluation of MLN8237 (NSC# 747888) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the clinical activity of MLN8237 (alisertib) in patients with recurrent or
persistent leiomyosarcoma of the uterus who have received one or two prior cytotoxic
therapies and the frequency of patients who survive progression-free for at least 6 months
after initiating therapy or have objective tumor response.
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of adverse events as assessed by Common
Terminology Criteria for Adverse Events version 4 (CTCAE v4) among women with leiomyosarcoma
treated with MLN8237.
II. To determine the distribution of progression-free survival (PFS) and overall survival
(OS).
TERTIARY OBJECTIVES:
I. To determine the relationship of Aurora A Kinase expression, measured by
immunohistochemistry, with objective response, PFS at 6 months, survival, and
progression-free survival.
OUTLINE:
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
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