Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 13
- 主要终点
- Progression-free Survival
研究概览
简要总结
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.
详细描述
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.
One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.
If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 documented metastatic or unresectable locally recurrent clear cell renal carcinoma
- •Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
- •Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
- •No prior bevacizumab
- •Measurable disease
- •Adequate liver and kidney function
- •Age 18 and older
排除标准
- •Acute MI within the past 6 months
- •Uncontrolled high blood pressure or history of hypertensive crisis
- •Clinically significant cardiovascular disease
- •Active brain cancer
- •Meningeal metastasis
- •Pregnant or lactating women
- •Prior treatment for another cancer less than 5 years ago
- •No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
- •No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
- •No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
- •No major surgical procedures, open biopsies or traumatic injury in past 28 days
- •No patients with peg tubes or feeding tubes
- •No patients with non healing wounds, ulcers or long bone fractures
- •No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
- •No symptomatic peripheral vascular disease
- •Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
研究组 & 干预措施
Weekly Avastin
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
干预措施: Bevacizumab (Drug)
Bi-weekly Avastin
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 18 months (expected)
Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Overall Survival (OS)(18 months)
- Overall Tolerability and Toxicity of High-dose Bevacizumab(18 months)
- Objective Response Rate(18 months)