Clinical Trial: Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uter

Brief Summary: This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Assess the activity of sunitinib malate, in terms of rate of progression-free survival for ≥ 6 months and objective tumor response, in patients with recurrent or persistent leiomyosarcoma of the uterus who have received 1 or 2 prior cytotoxic therapies.

II. Determine the frequency and severity of adverse events.

SECONDARY OBJECTIVES:

I. Determine the duration of progression-free survival and overall survival.

OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact., assessed up to 6 months ]
  • Objective tumor response according to GOG RECIST criteria [ Time Frame: Up to 5 years ]
  • Frequency and severity of adverse events as assessed by CTCAE v 3.0 [ Time Frame: Up to 5 years ]
    The frequency and severity of all toxicities will be tabulated.


Original Primary Outcome:

Current Secondary Outcome:

  • Duration of progression-free survival [ Time Frame: Up to 5 years ]
    Characterized graphically and using descriptive statistics such as median survival.
  • Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]
    Characterized graphically and using descriptive statistics such as median survival.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 19, 2006
Date Started: October 2006
Date Completion:
Last Updated: June 11, 2014
Last Verified: December 2012