An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the median progression-free survival, in terms of stable disease, of patients with newly diagnosed or recurrent/refractory angiosarcoma treated with bevacizumab.
Secondary
- Evaluate the treatment effect of bevacizumab on the objective response rate as assessed by modified RECIST criteria in patients with angiosarcoma.
- Evaluate the duration of response.
- Assess the treatment effect of bevacizumab on duration of overall survival.
- Explore the objective response by target tumor density changes on CT scan.
- Evaluate the safety and tolerability of bevacizumab in patients with angiosarcoma.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed angiosarcoma
- •Any stage disease
- •Must be deemed not surgically resectable (complete resection) and/or no other therapeutic modality is known to be curative
- •No angiosarcoma of a vessel wall
- •Newly diagnosed or recurrent/refractory disease
- •No prior tumor-related hemorrhage (any grade)
- •Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- •No CNS disease, brain metastases, or primary brain tumors
- •PATIENT CHARACTERISTICS:
- •ECOG performance status of 0 or 1
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 gm/dL (transfusion and epoetin alfa allowed)
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Urine protein:creatinine ratio ≤ 1.0
- •Total bilirubin ≤ 1.5 mg/dL
- •Aspartate aminotransferase < 5 times ULN
- •Alkaline phosphatase < 5 times ULN
- •PT/INR ≤ 1.5 times ULN
- •PTT ≤ 1.5 times ULN
- •Fertile patients must use effective contraception
- •Ejection fraction > 49% for patients with prior anthracycline therapy, ischemic cardiac disease, or history of heart failure
- •No uncontrolled active infection
- •No uncontrolled high blood pressure (defined as > 150/100 mm Hg)
- •No symptomatic congestive heart failure (New York Heart Association class II-IV), unstable angina, cardiac arrhythmia, or myocardial infarction within the past 6 months
- •No psychiatric illness or social situation that would limit study compliance
- •No serious, nonhealing wound, ulcer, or bone fracture
- •No evidence of bleeding diathesis or coagulopathy
- •No clinically significant peripheral vascular disease
- •Not pregnant or nursing
- •No seizures not controlled with standard medical therapy
- •No embolic or hemorrhagic stroke or prior transient ischemic attack
- •No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •No significant traumatic injury within the past 6 weeks
- •PRIOR CONCURRENT THERAPY:
- •No prior therapy with bevacizumab or other antiangiogenesis treatment
- •No major surgical procedure or open biopsy within the past 6 weeks
- •No more than 2 prior chemotherapy regimens
- •No fine-needle aspiration or core-needle biopsy or other minor surgical procedure within the past 7 days
- •No radiotherapy within the past 28 days
- •No concurrent chronic daily treatment with aspirin > 325 mg/day or nonsteroidal anti-inflammatory medications
- •No concurrent warfarin or any other anticoagulant (any dose)
- •No concurrent radiotherapy
- •No concurrent major surgery
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab
Bevacizumab treatment until disease progression or intolerance
干预措施: Bevacizumab (Biological)
结局指标
主要结局
Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.
时间窗: After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.
During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage). Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- Duration of Response.(After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.)
- Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival(After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years)
- Objective Response Rate in Patients Treated With Bevacizumab.(After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.)
- Evaluate the Toxicity of Bevacizumab.(Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years.)
研究者
Mark Agulnik
Principal Investigator
Northwestern University