Clinical Trial: Pazopanib for Treating Uterine Leiomyosarcoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II Evaluation of Pazopanib in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Brief Summary: The purpose of this study is to test any good and bad effects of the study drug pazopanib.

Detailed Summary:
Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

• Event free survival [ Time Frame: 6 months ]
  To estimate the proportion of patients with persistent or recurrent uterine leiomyosarcoma, who survive event-free for at least 6 months (EFS > 6 months; events associated with the endpoint are death, disease progression, or beginning a subsequent therapy) and the proportion of patients who have objective tumor response (complete or partial), treated with pazopanib.
• Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Every 4 weeks ]
  To determine the nature and degree of toxicity of pazopanib in this cohort of patients

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Progression-free survival [ Time Frame: Every 3 months from time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
  To estimate progression-free survival in patients with recurrent or persistent leiomyosarcoma of the uterus
• Event-free survival [ Time Frame: Every 3 months from time of study entry totime of progression or death, whichever occurs first, assessed up to 5 years ]
  To estimate event-free survival in patients with recurrent or persistent leiomyosarcoma of the uterus
• Overall survival [ Time Frame: Every 3 months from time of study entry totime of progression or death, whichever occurs first, assessed up to 5 years ]
  To estimate overall survival in patients with recurrent or persistent leiomyosarcoma of the uterus

Original Secondary Outcome: Same as current

Information By: Gynecologic Oncology Group

Dates:
Date Received: February 17, 2015
Date Started: March 2015
Date Completion:
Last Updated: November 17, 2015
Last Verified: November 2015