Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

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

- 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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate the activity of letrozole in post menopausal women with advanced estrogen (ER)/progesterone (PR)-positive uterine leiomyosarcoma.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Suzanne George, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Leiomyosarcoma
  • estrogen receptor positive
  • progesterone receptor positive
  • letrozole
  • Leiomyosarcoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115