NCT00626509Unknown2 期
Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
Gruppo Italiano Carcinoma Renale2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer.
PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- To compare the activity of sunitinib malate when administered before vs after cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal cell carcinoma.
- To compare the safety of these regimens in these patients.
Secondary
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Proven metastatic renal cell carcinoma
- •Measurable disease (according to RECIST criteria)
- •Eligible for cytoreductive nephrectomy
- •Primary tumor is considered amenable to surgical extirpation by the attending surgeon
- •Thrombosis of the inferior vena cava below the epathic veins allowed
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Adequate hematology and coagulation
- •Amylase and lipase normal
- •Adequate hepatic, renal, and cardiac function
- •Not pregnant
- •Negative pregnancy test
- •No uncontrolled hypertension and/or clinically significant cardiovascular events or disease within the past 12 months
- •No other cancer within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •No prior early nephrectomy due to clinical condition
- •No prior systemic therapy for renal cell carcinoma (e.g., chemotherapy, hormonal therapy, interferon, interleukin-2, lymphocyte-activated killer cells, or other biological response modifiers)
- •More than 12 days since prior potent CYP3A4 inducers, including any of the following:
- •Rifabutin
- •Carbamazepine
- •Phenobarbital
- •Phenytoin
- •St. John's wort
- •Efavirenz
- •Tipranavir
- •More than 7 days since prior potent CYP3A4 inhibitors, including any of the following:
- •Ketoconazole
- •Itraconazole
- •Clarithromycin
- •Erythromycin
- •Diltiazem
- •Verapamil
- •Delavirdine
- •Indinavir
- •Saquinavir
- •Ritonavir
- •Atazanavir
- •Nelfinavir
- •No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
- •No concurrent participation in any other treatment clinical trial
- •No concurrent palliative radiotherapy or surgery
- •No concurrent drugs with proarrhythmic potential, including any of the following:
- •Terfenadine
- •Quinidine
- •Procainamide
- •Disopyramide
- •Haloperidol
- •Risperidone
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Adverse events as assessed by NCI CTCAE v3.0
次要结局
- Time to progression
- Duration of response
- Overall survival
研究者
研究点 (2)
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