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

NCT00856050 | Completed Phase 2 Results DMC

• 1 other identifier: 08-341
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Leiomyosarcoma

Keywords

estrogen receptor positive; progesterone receptor positive; letrozole

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate at 12 Weeks

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

  12 weeks

Study Arms (1)

letrozole

EXPERIMENTAL

single arm trial - all patients received letrozole 2.5mg by mouth per day

Drug: letrozole

Interventions

letrozole DRUG

Taken orally once a day continuously

Also known as: Femara

letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Novartis: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leiomyosarcoma

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Suzanne George
• Organization: Dana-Farber Cancer Institute

sgeorge2@partners.org

617-632-5204

Study Officials

• Suzanne George, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 18, 2017
• Results First Posted: March 19, 2014

Record last verified: 2017-03

Locations

US (1)