NCT00717587Unknown2 期
A Histopathologic and Imaging Study of Renal Cell Carcinoma Vasculature in the Setting of Sunitinib Therapy Prior to Cytoreductive Nephrectomy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Sunitinib 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well sunitinib works when given before and after surgery in treating patients with stage IV kidney cancer.
详细描述
OBJECTIVES:
- To correlate histologic measures of tumor angiogenesis and VHL mutation/methylation status with clinical outcome in patients with stage IV renal cell carcinoma treated with sunitinib malate.
- To determine the effects of sunitinib malate on tumor vascular permeability by dynamic contrast-enhanced MRI and iodine I 124 chimeric monoclonal antibody G250 positron emission tomography (PET) after 2 weeks of therapy.
- To correlate steady-state plasma concentrations of sunitinib malate and angiogenic growth factors in serum with clinical outcome in these patients.
OUTLINE:
- Neoadjuvant therapy:Patients receive oral sunitinib malate once daily on days 1-14.
- Cytoreductive surgery: Patients undergo cytoreductive nephrectomy on day 16.
- Adjuvant therapy:Beginning at least 4 weeks after surgery, 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.
Patients undergo dynamic contrast-enhanced MRI with motexafin gadolinium and positron emission tomography with iodine I 124 chimeric monoclonal antibody G250 at baseline and after completion of neoadjuvant sunitinib malate (prior to cytoreductive nephrectomy).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Diagnosis of renal cell carcinoma
- •AJCC stage IV disease
- •Radiographic evidence of disease for which cytoreductive nephrectomy is deemed to be clinically indicated AND for which preoperative embolization is not deemed necessary by the surgeon
- •No history or clinical evidence of brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •WBC ≥ 3,000/mm³
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR serum creatinine clearance ≥ 40 mL/min
- •Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert's disease)
- •AST/ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
- •INR ≤ 1.5*
- •PTT normal*
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication
- •No hypertension that cannot be controlled by medications (i.e., diastolic BP ≥ 100 mm Hg despite optimal medical therapy)
- •No ongoing cardiac dysrhythmias ≥ grade 2 (according to NCI CTCAE v3.0)
- •No other concurrent malignancies
- •No concurrent serious illness including, but not limited to, any of the following:
- •Ongoing or active infection requiring parenteral antibiotics
- •Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina)
- •New York Heart Association class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •Peripheral vascular disease ≥ grade 2 within the past year
- •Psychiatric illness/social situation that would limit compliance with study requirements NOTE: *Patients who are taking warfarin must have documentation of an INR ≤ 1.5 and PTT normal prior to the initiation of anticoagulation to rule out a baseline coagulopathy
- •PRIOR CONCURRENT THERAPY:
- •At least 2 weeks since prior radiotherapy and recovered
- •Prior radiotherapy to a symptomatic site of metastatic disease is allowed
- •No prior systemic therapy
- •No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Tumor regression as assessed by RECIST criteria
研究者
研究点 (1)
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