NCT00556205撤回2 期
Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With 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
- 撤回
- 主要终点
- To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab.
研究概览
简要总结
The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.
详细描述
- Participants will receive one of two treatment possibilities. Since no one knows which of the study options is best, participants will be "randomized" to one fo the three treatment groups.
- Group 1 will stop their current treatment with sunitinib and receive a dose of bevacizumab once every 2 weeks. Group 2 will receive the standard treatment of sunitinib with the addition of bevacizumab.
- All study participants will undergo the same study procedures. These study procedures will include the following at intervals specified in the protocol: medical history review; vital signs; physical exam; urine analysis; EKG and CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 confirmed metastatic renal cell carcinoma with clear cell histology
- •Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol
- •Evidence of unidimensionally measurable disease based on RECIST criteria, with at least 1 measurable lesion
- •Radiographic evidence of disease progression defined by RECIST during or within 6 weeks of completion of sunitinib treatment
- •Participants must have received at least 14 doses of sunitinib therapy
- •Participants must enroll within 3 months of the last dose of sunitinib
- •Males or females, age of 18 years or older
- •ECOG Performance status 0-2
- •Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedures to NCI CTCAE version 3.0 grade 1 or less
- •Laboratory values as defined in protocol
- •4 weeks or more must have elapsed from the time of major surgery and subjects must have recovered from the procedure prior to day 1 of randomization
- •No anticipated need for major surgical procedure during the course of the study
- •2 weeks or more must have elapsed from the time of minor surgery and subjects must have recovered from the procedure prior to day 1 of randomization
- •4 weeks of more must have elapsed from the time of major radiotherapy prior to day 1 of randomization
排除标准
- •Prior treatment with bevacizumab
- •Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower
- •Prior systemic therapy for RCC with > 2 regimens
- •Systemic therapy other than sunitinib within 4 weeks of starting the study treatment
- •Uncontrolled high blood pressure
- •Any prior history of hypertensive crisis or hypertensive encephalopathy
- •History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 3 months prior to day 0
- •Any of the following within the 6 months prior to sudy drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, symptomatic congestive heart failure, or ejection fraction < 30%
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range without medication
- •History of or known brain metastases or spinal cord compression
- •NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment
- •Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- •Symptomatic peripheral vascular disease
- •Grade 3 or higher cardiac dysrhythmia or QT prolongation
- •Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
- •Pregnancy or breastfeeding or inadequate contraception
- •Significant thromboembolic event within 6 months
- •Evidence of bleeding diathesis or coagulopathy
- •Serious, non-healing wound, ulcer or bone fracture
- •Proteinuria at screening
- •Known hypersensitivity to any component of bevacizumab
- •Psychiatric illness/social situation that would limit compliance with study requirements
- •Previous or concurrent malignancy requiring active systemic therapy
研究组 & 干预措施
1
Active Comparator
Bevacizumab monotherapy 10 mg/kg IV q2 weeks
干预措施: Bevacizumab (Drug)
2
Active Comparator
Combination Sunitinib & Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule
干预措施: Sunitinib (Drug)
2
Active Comparator
Combination Sunitinib & Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule
干预措施: Bevacizumab (Drug)
结局指标
主要结局
To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab.
时间窗: Until tumor progression
次要结局
- To determine the overall response rate in this patient population.(Until tumor progression)
- To evaluate the safety and tolerability of these treatments in mRCC patients with disease progression on standard dose sunitinib.(Until tumor progression)
- To collect serum research samples for analysis of predictive biomarkers of response.(Two months)
研究者
Dror Michaelson, MD
Associate Professor of Medicine
Massachusetts General Hospital
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