NCT00445406已完成2 期
Bevacizumab and Pegylated Liposomal Doxorubicin as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer. A Multicenter, Single-Arm Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- bevacizumab and doxorubicin hydrochloride liposome
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 also may stop the growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with doxorubicin hydrochloride liposome may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with doxorubicin hydrochloride liposome works in treating women with locally recurrent or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of bevacizumab and doxorubicin hydrochloride liposome in women with locally recurrent or metastatic breast cancer.
Secondary
- Determine the efficacy of this regimen in these patients.
- Identify surrogate markers of angiogenesis, including vascular endothelial growth factor (VEGF), VEGF receptor 1, and matrix metalloproteinase 9, in patients treated with this regimen.
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
- •DISEASE CHARACTERISTICS:
- •Cytologically or histologically confirmed breast cancer
- •Metastatic OR locally recurrent disease
- •Unresectable disease
- •Not amenable to radiotherapy
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Measurable disease must be outside irradiated areas
- •ErbB2-negative disease by immunohistochemistry (negative or 1+) or fluorescent in situ hybridization (FISH)
- •No known CNS metastases, even if previously treated
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •WHO performance status 0-1
- •LVEF ≥ 55%
- •Hemoglobin ≥ 10.0 g/dL
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin < 2 times upper limit of normal (ULN)
- •ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •Alkaline phosphatase (AP) ≤ 2.5 times ULN
- •AP > 2.5 times ULN and ≤ 6 times ULN allowed if ALT ≤ 1.5 times ULN
- •AP > 6 times ULN allowed if ALT normal
- •Creatinine ≤ 1.5 times ULN
- •Proteinuria < 2+ by dipstick OR protein ≤ 1 g/24hr-urine collection
- •INR ≤ 1.5 OR Quick ≥ 70%
- •aPTT ≤ 1.5 times ULN
- •No peripheral neuropathy > grade 2
- •No history or evidence of hereditary bleeding diathesis or coagulopathy with the risk of bleeding
- •No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg, measured repeatedly at > 2 visits despite adequate treatment with ≥ 2 different antihypertensive drugs
- •No clinically significant cardiovascular disease, including the following:
- •Cerebrovascular accident or stroke within the past 6 months
- •Myocardial infarction within the past 6 months
- •Unstable angina
- •New York Heart Association class II-IV congestive heart failure
- •Serious cardiac arrhythmia (e.g., ventricular arrhythmia, high-grade atrioventricular-block) not controlled by medication or requiring medication which might interfere with regularity of the study treatment
- •No serious nonhealing wound, active peptic ulcer, nonhealing bone fracture, or bleeding skin metastases
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •No active infection requiring IV antibiotics
- •No known hypersensitivity to any of the study drugs or excipients
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- •No evidence of any other disease that contraindicates the use of an investigational drug, that may affect patient compliance with study routines, or places the patient at high risk for treatment-related complications including, but not limited to, the following:
- •Metabolic dysfunction
- •Physical examination finding
- •Psychological dysfunction
- •Clinical laboratory finding giving reasonable suspicion of a disease or condition
- •No known CNS disease unrelated to cancer (e.g., uncontrolled seizures), unless adequately treated with standard medical therapy
- •No high-risk factors for bleeding, including the following:
- •Coagulation parameters outside range
- •Need for concurrent anticoagulant therapy
- •Insufficient time gap after surgical procedures
- 另有 25 项未显示
排除标准
- 未提供
结局指标
主要结局
bevacizumab and doxorubicin hydrochloride liposome
时间窗: Until treatment ends
Determine the safety and tolerability of bevacizumab and doxorubicin hydrochloride liposome.
次要结局
- Progression-free survival(Periodically)
- Overall survival(Life-long)
- Determine the efficacy of this regimen(Until treament ends)
- Identify surrogate markers of angiogenesis(Until treatment ends)
- Overall (complete and partial) response as measured by RECIST criteria(Periodically)
- Time to treatment failure(Until treatment ends)
研究者
研究点 (2)
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