Clinical Trial: Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma

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

Official Title: Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma

Brief Summary: The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).

Detailed Summary:

  • Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:
  • Visit 1 (Day 1): physical examination, vital signs and blood work
  • Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
  • Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
  • Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Progression Free Survival Rate at 12 Weeks [ Time Frame: 12 weeks ]

Data below are reported as progression free rate (%).


Original Primary Outcome: Evaluate the Activity of Letrozole in Post Menopausal Women With Advanced Estrogen (ER)/Progesterone (PR)-Positive Uterine Leiomyosarcoma. [ Time Frame: 3 years ]

Current Secondary Outcome:

Original Secondary Outcome: To evaluate the safety of letrozole in this patient population. [ Time Frame: 3 years ]

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: March 4, 2009
Date Started: February 2009
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017