A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
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 or by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
I. To determine the clinical outcome (response rate and overall progression-free survival) in metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy.
II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma.
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-proven advanced RCC with a component of clear cell histology
- •Measurable disease per RECIST criteria
- •ECOG performance status 0-1
- •Prior nephrectomy is NOT required
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x laboratory upper limit of normal (ULN)
- •Total serum bilirubin ≤ 2.0 x ULN
- •Absolute neutrophil count (ANC) ≥ 1500/uL
- •Platelets ≥ 100,000/uL
- •Hemoglobin ≥ 8.0 g/dL (transfusion permitted)
- •Serum calcium ≤ 12.0 mg/dL
- •Serum creatinine ≤ 2.5 mg/dL
- •Patients with history of brain metastases can be enrolled at a minimum of 2 weeks following the completion of surgery, gamma knife or whole brain radiotherapy; repeat brain MRI not required for eligibility
- •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
排除标准
- •Prior systemic treatment for advanced RCC. Prior adjuvant therapy (any drug) is allowed if end of adjuvant therapy was more than 1 year prior to start of sunitinib on this protocol.
- •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
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
时间窗: after 6 months of treatment (4 cycles)
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
次要结局
- Change in Circulating Tumor Cells(Pre-treatment, day 1, and day 28 of every cycle)
- Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype(Day 28 of each cycle)