Status:
TERMINATED
Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Novartis
Conditions:
Leiomyosarcoma
Uterine Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 co...
Detailed Description
Letrozole is an aromatase inhibitor. Aromatase is the enzyme that produces estrogen in post-menopausal women. By interfering with the production of estrogen triggered by aromatase, letrozole reduces t...
Eligibility Criteria
Inclusion
- 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.
- Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2.5 mg/dL.
- Aspartate transaminase (SGOT) must be less than 3x institutional upper limit of normal.
- Patients must have recovered from the effects of prior surgery.
- No more than 12 weeks must have elapsed from hysterectomy.
- Patients must be 18 years or older.
Exclusion
- 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.
- Presence of carcinomatous meningitis.
- Patients currently receiving chemotherapy or radiation therapy.
Key Trial Info
Start Date :
December 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00414076
Start Date
December 19 2006
End Date
July 13 2017
Last Update
November 20 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030