A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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 the total amount of estrogen in the body. As a result, less estrogen can reach cancer cells, thus preventing their growth.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. These exams, tests, or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.
Your complete medical history will be recorded, and you will have a physical exam (including a pelvic exam). Your vital signs and blood pressure will be measured. Blood (about 2-3 teaspoons) will be drawn for routine tests. You will also have a blood test (1 teaspoon) to check your cholesterol. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a chest x-ray, and either a computed tomography (CT) scan or a magnetic resonance imaging (MRI) to check the status of the disease. Your doctors will test previously collected tumor tissue to learn if the estrogen receptor is positive or negative.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. Group 1 will receive letrozole by mouth once a day. Group 2 will receive no treatment. Both groups will be followed closely every 3 months. You will have an equal chance of being placed in either group.
If you are in Group 1, you will take letrozole by mouth every day for 12 weeks. Every 12 weeks is considered a study "cycle." You will only be given the amount of drug needed for 1 cycle of therapy at a time. You will keep a diary during the study that will list when and how much drug you took. This diary will be reviewed after each cycle of therapy by the research nurse or doctor and filed in your chart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Letrozole
Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.
干预措施: Letrozole (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Every 12 weeks
Number of participants progressed or death from study entry.
次要结局
未报告次要终点