NCT00856050

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

* 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

Conditions

• Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	letrozole	Taken orally once a day continuously

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-01-01
• Completion: 2014-03-01
• First posted: 2009-03-05
• Last updated: 2017-04-18
• Results posted: 2014-03-19

Locations

1 site across 1 country: United States