Status:
COMPLETED
Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Novartis
Conditions:
Leiomyosarcoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 wor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00856050
Start Date
February 1 2009
End Date
March 1 2014
Last Update
April 18 2017
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115