Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 91
- 主要终点
- 6-month Progression-free Survival (PFS) Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab.
Secondary
- To determine the overall survival of patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the confirmed response rate in patients treated with this regimen.
- To determine the duration of response in patients treated with this regimen.
- To determine the time to treatment failure in patients treated with this regimen.
- To determine the quality of life of 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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
paclitaxel + gemcitabine + bevacizumab
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after every other course, and then after completion of treatment.
After completion of study treatment, patients are followed periodically for 5 years.
干预措施: bevacizumab (Biological)
paclitaxel + gemcitabine + bevacizumab
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after every other course, and then after completion of treatment.
After completion of study treatment, patients are followed periodically for 5 years.
干预措施: gemcitabine hydrochloride (Drug)
paclitaxel + gemcitabine + bevacizumab
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after every other course, and then after completion of treatment.
After completion of study treatment, patients are followed periodically for 5 years.
干预措施: paclitaxel albumin-stabilized nanoparticle formulation (Drug)
结局指标
主要结局
6-month Progression-free Survival (PFS) Rate
时间窗: at 6 months
The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
次要结局
- Confirmed Response (Complete or Partial Response) Rate(Up to 5 years)
- Time to Treatment Failure(Up to 5 years)
- Duration of Response(Up to 5 years)
- PFS Time(Up to 5 years)
- Overall Survival Time(Up to 5 years)
- Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8(From baseline to end of Cycle 8; Up to 24 weeks)