NCT00378911已完成2 期
A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Assess the activity of sunitinib malate, in terms of rate of progression-free survival for ≥ 6 months and objective tumor response, in patients with recurrent or persistent leiomyosarcoma of the uterus who have received 1 or 2 prior cytotoxic therapies.
II. Determine the frequency and severity of adverse events.
SECONDARY OBJECTIVES:
I. Determine the duration of progression-free survival and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed leiomyosarcoma of the uterus
- •Recurrent or persistent disease
- •Refractory to curative therapy or established treatments
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •Ascites and pleural effusions are not considered measurable disease
- •Must have ≥ 1 target lesion to assess response
- •Tumors in a previously irradiated field are considered non-target lesions unless there is documented progression or biopsy-confirmed persistence ≥ 90 days after completion of radiotherapy
- •Received at least 1 but no more than 2 prior cytotoxic regimens
- •Initial treatment may have included high-dose chemotherapy, consolidation, or extended therapy administered after surgery or nonsurgical assessment
- •Cytotoxic regimens may have included any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
- •Not a candidate for a higher priority GOG protocol
- •No known brain metastases
- •GOG performance status 0-2 (for patients who have received 1 prior regimen) OR GOG 0-1 (for patients who have received 2 prior regimens)
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •SGOT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 1.5 times ULN
- •QTc < 500 msec
- •LVEF normal by echocardiogram
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- •Patients with a pre-existing thyroid abnormality unable to maintain normal thyroid function with medication are not eligible
- •No significant EKG abnormalities (i.e., no history of serious ventricular arrhythmia OR EKG with ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •No sensory or motor neuropathy > grade 1
- •No NYHA class III-IV congestive heart failure
- •NYHA class II cardiac dysfunction allowed
- •History of NYHA class II heart failure that is asymptomatic on treatment allowed
- •No active infection requiring antibiotics
- •No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
- •No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
- •No gastrointestinal tract disease resulting in an inability to take oral medication
- •No requirement for IV alimentation
- •No active peptic ulcer disease
- •No other condition that would impair ability to swallow and retain study drug
- •No serious or nonhealing wound, ulcer, or bone fracture
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- •No cerebrovascular accident or transient ischemic attack within the past year
- •No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or symptomatic congestive heart failure within the past year
- •No pulmonary embolism within the past year
- •No uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infections
- •Psychiatric illness or social situations that would preclude study compliance
- •Recovered from prior surgery, chemotherapy, or radiotherapy
- •Prior anthracycline exposure and central thoracic radiation that included the heart allowed provided patient has New York Heart Association (NYHA) class II cardiac function
- •At least 1 week since prior hormonal therapy
- 另有 43 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (sunitinib malate)
Experimental
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From study entry until disease progression, death or date of last contact., assessed up to 6 months
Frequency and severity of adverse events as assessed by CTCAE v 3.0
时间窗: Up to 5 years
The frequency and severity of all toxicities will be tabulated.
Objective tumor response according to GOG RECIST criteria
时间窗: Up to 5 years
次要结局
- Duration of progression-free survival(Up to 5 years)
- Duration of overall survival(From entry into the study to death or the date of last contact, assessed up to 5 years)
研究者
研究点 (1)
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