NCT00591188已完成2 期
Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
Kidney Cancer Research Bureau1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
研究概览
简要总结
The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed renal carcinoma
- •CT-confirmed metastatic sites
- •Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
- •Disease progression after IL-2
- •Age 18 or older
- •ECOG performance status 1-3
- •Life expectancy ≥ 2 months
- •WBC ≥ 3,000/mm3
- •Platelet count ≥ 100,000/mm3
- •Hemoglobin ≥ 7.5 g/dL
- •Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
- •Total bilirubin ≤ 1.5 mg/dL
- •AST ≤ 3.0 times normal
- •Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
- •Not pregnant or nursing
- •No history of autoimmune
- •No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
- •No CNS metastases by neurologic exam and/or MRI
- •No history of seizure disorders
- •No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
- •No other malignancy
- •Written informed consent
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
All patients will receive capecitabine and interferon-alpha.
干预措施: capecitabine, interferon-alpha (Drug)
结局指标
主要结局
Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
时间窗: one year
次要结局
- Evaluate the safety and tolerability of the capecitabine and interferon combination(one year)
- Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens(one year)
研究者
研究点 (1)
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