A Phase II Study of Bevacizumab in Combination With Vinorelbine in Stage IV Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
研究概览
简要总结
Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells
详细描述
OBJECTIVES:
I. Determine the complete and partial response rates in patients with stage IV breast cancer treated with concurrent bevacizumab and vinorelbine.
II. Determine the side effects of this regimen in these patients. III. Determine the time to disease progression in patients treated with this regimen.
IV. Determine the time on study (a reflection of time to progression, treatment-related side effects, and patient preference) of patients treated with this regimen.
V. Assess urine protein/creatinine ratio and serum complement levels as screening measures for renal injury in patients treated with bevacizumab.
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
- •Histologically or cytologically confirmed stage IV breast cancer
- •Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
- •Must meet 1 of the following criteria:
- •Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
- •Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
- •At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •No CNS metastases by CT scan or MRI within the past 6 weeks
- •No prior or concurrent primary CNS tumor on physical exam
- •Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
- •HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
- •Hormone receptor status:
- •Not specified
- •Male or female
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 3 months
- •Absolute neutrophil count at least 1,500/mm^3
- •Hemoglobin at least 9 g/dL
- •Platelet count at least 100,000/mm^3
- •No prior bleeding diathesis or coagulopathy
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •INR no greater than 1.5
- •Creatinine less than 2 mg/dL
- •Urine protein no greater than +1 by dipstick
- •Urine protein less than 500 mg by 24-hour urine collection
- •LVEF at least 50%
- •No prior stroke
- •No New York Heart Association class II-IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication, including atrial fibrillation requiring systemic anticoagulation
- •No grade II or greater peripheral vascular disease within the past year
- •No clinically significant peripheral artery disease
- •No deep vein thrombosis or embolism within the past 5 years
- •No arterial thromboembolic event within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •No other significant cardiovascular disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No evidence of seizures not controlled with standard medical therapy
- •No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study
- •Prior mild infusion reaction to trastuzumab allowed
- •No serious non-healing wound, ulcer, or bone fracture
- •No significant traumatic injury within the past 4 weeks
- •No other concurrent illness (such as active infection) that would require active treatment or preclude study
- 另有 28 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (bevacizumab, vinorelbine tartrate)
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
干预措施: vinorelbine tartrate (Drug)
Treatment (bevacizumab, vinorelbine tartrate)
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
干预措施: bevacizumab (Biological)
Treatment (bevacizumab, vinorelbine tartrate)
Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
时间窗: Up to 6 years
次要结局
- Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0(Up to 6 years)
- Time to progression(Time from the first treatment on study until the time of documented disease progression, assessed up to 6 years)