A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Response Rate to Bevacizumab in This Population.
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the progression-free survival when bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.
- To further evaluate the safety of bevacizumab in these patients.
Secondary
- To examine, in a preliminary manner, the response rate to bevacizumab in these patients.
- To collect and store blood and urine samples for future analysis.
- To evaluate overall survival when bevacizumab is administered to these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed papillary renal cell carcinoma (RCC)
- •Unresectable and/or metastatic disease
- •Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 10 mm by spiral CT scan
- •No known CNS (central nervous system) disease
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- •Life expectancy > 6 months
- •ANC (absolute neutrophil count) ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10.0 g/dL
- •Total bilirubin ≤ 2.0 mg/dL
- •AST (aspartate aminotransferase) and ALT (Alanine transaminase) < 3 times normal
- •Creatinine clearance > 50 mg/mL
- •Calcium < 12 mg/dL (when corrected for level of serum albumin)
- •No known HIV infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- •Inadequately controlled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications)
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association class II-IV congestive heart failure
- •Myocardial infarction or unstable angina within the past 6 months
- •Stroke or transient ischemic attack within the past 6 months
- •Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- •Symptomatic peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Significant traumatic injury within the past 28 days
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •Serious, non-healing wound, ulcer, or bone fracture
- •Proteinuria at screening as demonstrated by either of the following:
- •Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
- •Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein > 1g
- •Known hypersensitivity to any component of bevacizumab
- •PRIOR CONCURRENT THERAPY:
- •No prior systemic treatment for metastatic papillary RCC
- •At least 4 weeks since prior palliative radiotherapy of painful areas
- •More than 28 days since prior major surgical procedure or open biopsy
- •No concurrent major surgical procedure
- •More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
- •Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at high-risk for arterial thromboembolic disease
研究组 & 干预措施
Bevacizumab
15 mg/kg over 90 minutes
干预措施: bevacizumab (Biological)
结局指标
主要结局
Response Rate to Bevacizumab in This Population.
时间窗: Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.
时间窗: Up to 2 years
Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Safety of Bevacizumab in This Population of Patients(Up to 2 years)
研究者
Paul Monk
Principal Investigator
Ohio State University Comprehensive Cancer Center