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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00856050
• Collaborator: Brigham and Women's Hospital (Other), Novartis (Industry)
• Enrollment: 27
• Location: 1
• Arm: 1
• Duration (Months): 60.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Leiomyosarcoma	Drug: letrozole	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day	Drug: letrozole; Taken orally once a day continuously; Other Names: Femara

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival Rate at 12 Weeks [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Suzanne George, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzanne George, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00856050
• Other Study ID Numbers: 08-341
• First Posted: Mar 5, 2009
• Last Update Posted: Apr 18, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Suzanne George, MD, Principal Investigator, Dana-Farber Cancer Institute: estrogen receptor positive; progesterone receptor positive; letrozole
• Additional relevant MeSH terms: Leiomyosarcoma; Letrozole

Study Results

Participant Flow

Pre-assignment Detail	27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.

Arm/Group Title	Letrozole
Arm/Group Description	Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
Period Title: Overall Study
STARTED	26
COMPLETED	26
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Letrozole
Arm/Group Description	letrozole 2.5mg by mouth per day
Overall Participants	26
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	56
Sex: Female, Male (Count of Participants)
Female	26 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival Rate at 12 Weeks
Description	Data below are reported as progression free rate (%).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.

Arm/Group Title	Letrozole
Arm/Group Description	letrozole 2.5mg by mouth per day
Measure Participants	26
Number (90% Confidence Interval) [percentage of participants]	46 176.9%

Adverse Events

Arm/Group Title	Letrozole
Arm/Group Description	Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
All Cause Mortality
	Letrozole
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Letrozole
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	Letrozole
	Affected / at Risk (%)	# Events
Total	20/26 (76.9%)
Gastrointestinal disorders
Diarrhea w/o prior colostomy	2/25 (8%)
Nausea	4/25 (16%)
General disorders
Fatigue	4/25 (16%)
Musculoskeletal and connective tissue disorders
Joint= pain	5/25 (20%)
Muscle= pain	7/25 (28%)
Vascular disorders
Hot flashes	17/25 (68%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.