NCT00459979已完成2 期
A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors
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
- 30
- 试验地点
- 1
- 主要终点
- Response to Sunitinib Therapy
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response, according to the operating surgeon, to undergo nephrectomy after sunitinib therapy.
- To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors, including analysis of the morbidity of surgery after sunitinib therapy
- To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy.
OUTLINE: A single arm phase II study of sunitinib in patients with unresectable renal cell carcinoma (RCC) will be conducted, including patients with and without distant metastases.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Surgery is performed if and when primary tumor becomes resectable. Patients with residual and/or metastatic disease may resume sunitinib malate within 8 weeks after surgery.
After completion of study treatment, patients are followed periodically.
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
- •Histologically or cytologically confirmed renal cell carcinoma (any histology) based on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This can include pathology read as adenocarcinoma consistent with renal origin.
- •Unresectable primary tumor due to any of the following factors or various combinations thereof:
- •Large tumor size (> 15 cm)
- •Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels)
- •Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest)
- •Proximity to vital structures (e.g., mesenteric vasculature)
- •Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (<50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable. The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability.
- •Patients with history of brain metastases can be enrolled 2 weeks following the completion of gamma knife or whole brain radiotherapy.
- •ECOG performance status (PS) 0-1 or Karnofsky PS >/=70%
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 times upper limit of normal (ULN)
- •Total Serum Bilirubin ≤ 1.5 times ULN
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- •Serum calcium ≤ 12.0 mg/dL
- •Creatinine ≤ 2.5 mg/dL
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •The presence of any of the following will exclude a patient from study enrollment:
- •Prior systemic treatment for RCC.
- •Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the primary renal tumor are eligible provided all other eligibility criteria are met.
- •Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
- •Hypertension that cannot be controlled by medications to < 160/90 mmHg.
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •Pregnancy or breastfeeding.
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
研究组 & 干预措施
Sunitinib
Experimental
干预措施: sunitinib malate (Drug)
Sunitinib
Experimental
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Response to Sunitinib Therapy
时间窗: 1 year from start of treatment
Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason
次要结局
- The Number of Patients With Any Type of Complication or Adverse Event(1 year from start of treatment)
- Progression Free Survival(1 year from start of treatment)
- Percent Decrease of Diameter of Primary Tumors(1 year from start of treatment)
- Number of Tumors Which Decreased in Size(1 year from start of treatment)
- Number of Tumors With 30% Reduction in Size(1 year from start of treatment)
- Median Size Reduction Among Tumors With Some Shrinkage(1 year from start of treatment)
研究者
研究点 (1)
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