An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Percentage of Participants With Disease Progression or Death
研究概览
简要总结
This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients, >=18 years of age;
- •metastatic renal cell cancer of predominantly clear cell type;
- •>=1 measurable lesion.
排除标准
- •prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
- •ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: Interferon alfa-2a (Drug)
1
干预措施: Vinblastine (Drug)
结局指标
主要结局
Percentage of Participants With Disease Progression or Death
时间窗: Days 0, 91, 182, 273, 365, 456, and 547
Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
PFS - Time to Event
时间窗: Days 0, 91, 182, 273, 365, 456, and 547
PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method
次要结局
- Percentage of Participants With Objective Response (OR)(Baseline and Cycles 3, 6, 9, 13, and 17)
- Overall Survival (OS)(Baseline, Day 1 of every cycle to disease progression or death (up to Week 102))