NCT01024205已完成2 期
Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]
Barts and the London School of Medicine and Dentistry2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
研究概览
简要总结
RATIONALE: Sunitinib malate 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 malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine if neoadjuvant sunitinib malate can achieve a clinical benefit of 70% or more to the primary renal tumor prior to surgery and adjuvant sunitinib malate in patients with metastatic renal cancer.
Secondary
- Determine the time to radiological progression in these patients.
- Determine the overall survival of these patients.
- Determine the proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate.
- Determine the translational endpoints.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed renal cell carcinoma
- •Measurable metastatic disease on CT/MRI imaging
- •Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell disease
- •No prior therapy for renal cancer
- •Judged by the treating physician to have the potential to derive clinical benefit from this treatment
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1 x 10^9/L (without growth factor support)
- •Platelet count ≥ 75 x 10^9/L
- •Total bilirubin ≤ 2 times upper limit of normal (ULN) (except for patients with Gilbert disease)
- •Serum creatinine ≤ 2 times ULN
- •Serum transaminases < 5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
- •Willing and able to comply with scheduled visits, treatment plan, and laboratory tests and other study procedures
- •No congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 6 months, or ongoing severe or unstable arrhythmia requiring medication
- •No other severe acute or chronic medical or psychiatric condition, or abnormal laboratory results that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration or would make the patient inappropriate for entry into this study
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 7 days since prior and no concurrent potent CYP3A inhibitors, including any of the following:
- •Ketoconazole
- •Itraconazole
- •Clarithromycin
- •Erythromycin
- •Diltiazem
- •Verapamil
- •Delavirdine
- •Indinavir
- •Saquinavir
- •Ritonavir
- •Atazanavir
- •Nelfinavir
- •At least 12 days since prior and no concurrent potent CYP3A inducers, including any of the following:
- •Rifabutin
- •Carbamazepine
- •Phenobarbital
- •Phenytoin
- •St. John's wort
- •Efavirenz
- •Tipranavir
- •Concurrent radiotherapy allowed provided sunitinib malate is stopped one day before and resumed one day after radiotherapy
- •Concurrent coumarin-derivative anticoagulants (e.g., warfarin) allowed (≤ 2 mg/day) for prophylaxis of thrombosis
- •No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide)
- •No other concurrent investigational drug or participation in another clinical trial (unless approved by the sponsor)
排除标准
- 未提供
结局指标
主要结局
Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
次要结局
- Overall survival
- Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate
- Time to radiological progression
研究者
研究点 (2)
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