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

Leiomyosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856050
• Other study ID #: 08-341
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2009
• Last updated: April 24, 2014
• Start date: February 2009
• Est. completion date: March 2014

Study information

• Verified date: February 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective

• Patients must be postmenopausal. Postmenopausal is defined as any of the following:

1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range

• Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue

• Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment

• 18 years of age or older

• Life expectancy of 3 months or more

• ECOG Performance Status 0, 1, or 2

• No limit to number of prior chemotherapies or biologics

• Normal organ function as outlined in the protocol

• Resolution of clinically significant toxicities related to prior therapies

Exclusion Criteria:

• Pre-menopausal women

• Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)

• Palliative radiotherapy within 2 weeks of study entry

• Major surgery within 2 weeks of study entry

• Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)

• Participants may not be receiving any other concomitant investigational agents

• Uncontrolled brain or central nervous system metastases

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyosarcoma

Intervention

Drug:
• letrozole
Taken orally once a day continuously

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Activity of Letrozole in Post Menopausal Women With Advanced Estrogen (ER)/Progesterone (PR)-Positive Uterine Leiomyosarcoma.	The progression free survival rate at 12 weeks was 46% (90%CI, 29%-64%)	3 years	No