Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma (NCT00414076) | Clinical Trial Compass
TerminatedPhase 2
Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
Stopped: Low accrual
United States9 participantsStarted 2006-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Patients must have signed an approved informed consent.
✓. Histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (determined by surgical staging or radiologic imaging).
✓. Tumors must express ER positivity by immunohistochemistry (ER expression \>10% by immunohistochemistry).
✓. Patients must have a hysterectomy and bilateral oophorectomy prior to initiation of therapy.
✓. 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.
✓. Patients must have a Zubrod performance status of 0, 1, or 2.
✓. 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.
✓. Patients must have an adequate renal function as documented by serum creatinine less than or equal to 2.0 mg/dL.
Exclusion criteria
✕. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant Mullerian tumors).
✕. 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.
. 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.
✕. Patients who were taking or have a history of taking letrozole or another aromatase inhibitor.
✕. Patients with active or uncontrolled systemic infection.
✕. 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%.
✕. Patients who are pregnant or breast-feeding.
✕. Presence of clinically apparent untreated central nervous system metastases.