Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Condition: Leiomyosarcoma
MeSH terms: Leiomyosarcoma
Intervention: letrozole
Intervention description: Taken orally once a day continuously
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: estrogen receptor positive; progesterone receptor positive; letrozole

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).
    

Eligibility criteria:

        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