NCT00072046已完成3 期
A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 493
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer).
PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab.
Secondary
- Compare the time to disease progression and objective response rates in patients treated with these regimens.
- Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed renal cell carcinoma (RCC)
- •Conventional clear cell carcinoma
- •Metastatic or unresectable disease
- •The following characteristics and cellular types are excluded:
- •True papillary
- •Sarcomatoid features without a clear cell component
- •Chromophobe
- •Oncocytoma
- •Collecting duct tumor
- •Transitional cell carcinoma
- •Measurable or nonmeasurable disease, including any of the following:
- •Unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI
- •The following are considered nonmeasurable disease:
- •Small lesions
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Irradiated lesions, unless progression is documented after radiotherapy
- •RCC paraffin tissue blocks or unstained slides must be available
- •No evidence of prior or concurrent CNS metastases by MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No history of clinically significant bleeding
- •AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No proteinuria > 1+
- •Proteinuria ≥ 2+ allowed provided protein is < 2 g/24-hour urine collection
- •Cardiovascular
- •No deep venous thrombosis within the past year
- •No cerebrovascular accident within the past year
- •No peripheral vascular disease with claudication on < 1 block
- •No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (diastolic) while on medication
- •No New York Heart Association class II-IV congestive heart failure
- •No angina pectoris requiring nitrate therapy
- •No myocardial infarction within the past 6 months
- •No other significant cardiovascular disease
- •No pulmonary embolus within the past year
- 另有 30 项未显示
排除标准
- 未提供
研究组 & 干预措施
Interferon + bevacizumab
Experimental
Addition of bevacizumab to interferon alfa 2b treatment
干预措施: recombinant interferon alfa (Biological)
Interferon + bevacizumab
Experimental
Addition of bevacizumab to interferon alfa 2b treatment
干预措施: bevacizumab (Biological)
Interferon
Experimental
Treatment with interferon alfa 2b
干预措施: recombinant interferon alfa (Biological)
结局指标
主要结局
Overall Survival
时间窗: 5 years
次要结局
- Time to progression(q 3 cycles)
- Toxicity(q cycle)
研究者
研究点 (493)
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