NCT00570882已完成2 期
A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
研究概览
简要总结
This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component
- •Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- •Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
- •ECOG performance status 2 or better
- •Age 18 years or older
- •Adequate bone marrow, hepatic, and renal function
- •Life expectancy of > 3 months
- •Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
排除标准
- •Known spinal cord compression or carcinomatous meningitis
- •Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
- •Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy)
- •Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
- •Pregnancy or breast feeding.
- •Other severe acute or chronic medical or psychiatric condition
- •Prior treatment on sunitinib, sorafenib, or bevacizumab.
研究组 & 干预措施
Sunitinib 4/2
Active Comparator
Sunitinib 50 mg PO 4-week on and 2-week off
干预措施: Sunitinib 4/2 (Drug)
Sunitinib 2/1
Experimental
Sunitinib 50 mg PO 2-week on 1-week off
干预措施: Sunitinib 2/1 (Drug)
结局指标
主要结局
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
时间窗: 12 months
From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.
次要结局
- quality of life(12 months)
- Progression free survival(12 months)
- Adverse events(about 12 months)
- Overall survival(36 months)
- Overall response rate(6 months)
研究者
JLee
Associate professor
Asan Medical Center
研究点 (3)
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