Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
Condition: Leiomyosarcoma; Uterine Neoplasm
MeSH terms: Leiomyosarcoma; Uterine Neoplasms
Intervention: Letrozole
Intervention description: 2.5 mg Tablet By Mouth Daily for 12 Weeks.
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uterine Leiomyosarcoma; Uterine Neoplasm; Uterine Sarcomas; Uterine Cancer; Uterus; LMS; ER Positivity; Femara; Letrozole

Summary:

      The goal of this clinical research study is learn if taking Femara (letrozole) after a
      hysterectomy (surgical removal of the uterus) for uterine leiomyosarcoma will delay or
      prevent the cancer from coming back.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have signed an approved informed consent.

          2. Histologically confirmed uterine leiomyosarcoma with disease limited to the uterus
             (determined by surgical staging or radiologic imaging).

          3. Tumors must express ER positivity by immunohistochemistry (ER expression >10% by
             immunohistochemistry).

          4. Patients must have a hysterectomy and bilateral oophorectomy prior to initiation of
             therapy.

          5. All patients must have no measurable disease. Measurable disease is defined as lesions
             that can be measured by physical examination or by means of imaging techniques.
             Imaging must be done within 6 weeks of study entry.

          6. Patients must have a Zubrod performance status of 0, 1, or 2.

          7. Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils +
             bands) of greater than 1,000/Fl, a hemoglobin level of greater than or equal to 9.0
             gm/dL and a platelet count of greater than 75,000/dL.

          8. Patients must have an adequate renal function as documented by serum creatinine less
             than or equal to 2.0 mg/dL.

          9. Patients must have adequate hepatic function as documented by a serum bilirubin less
             than or equal to 2.5 mg/dL.

         10. Aspartate transaminase (SGOT) must be less than 3x institutional upper limit of
             normal.

         11. Patients must have recovered from the effects of prior surgery.

         12. No more than 12 weeks must have elapsed from hysterectomy.

         13. Patients must be 18 years or older.

        Exclusion Criteria:

          1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant Mullerian
             tumors).

          2. Patients with any other severe concurrent disease, which would make the patient
             inappropriate for entry into this study, including significant hepatic, renal, or
             gastrointestinal diseases.

          3. Patients with a history of prior malignancy except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
             patient has been disease-free for at least five years.

          4. Patients who were taking or have a history of taking letrozole or another aromatase
             inhibitor.

          5. Patients with active or uncontrolled systemic infection.

          6. Patients with history of uncontrolled cardiac disease; i.e., uncontrolled
             hypertension, unstable angina, recent myocardial infarction (within prior 6 months),
             uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction
             under 40%.

          7. Patients who are pregnant or breast-feeding.

          8. Presence of clinically apparent untreated central nervous system metastases.

          9. Presence of carcinomatous meningitis.

         10. Patients currently receiving chemotherapy or radiation therapy.