NCT00482755已完成2 期
A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Feasibility
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.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with newly diagnosed stage II or stage IIIA breast cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of neoadjuvant sunitinib malate in patients with newly diagnosed, resectable stage II-IIIA breast cancer.
Secondary
- Determine the nature, severity, and frequency of adverse events in patients treated with this drug.
- Determine the response rate in patients treated with this drug.
- Evaluate markers of angiogenesis (e.g., VEGF receptor, platelet-derived growth factor receptor, circulating plasma VEGF, sVEGFR-2, sVEGFR-3, sKIT, and tumor vascularity) both pre- and post-treatment.
- Examine the role of both host- and tumor-specific genes pertaining to response and toxicity.
- Compare tumor vascular parameters pre- and post-treatment using DCE-MRI.
- Compare cell death and tumor microcirculation pre- and post-treatment using contrast-enhanced spectroscopic and microbubble contrast-enhanced ultrasound.
- Compare tumor metabolic activity pre- and post-treatment using fludeoxyglucose F 18-PET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Newly diagnosed disease
- •Stage II-IIIA (T1c, T2, or T3) disease
- •Unifocal disease
- •Resectable disease
- •Tumor must be suitable for multiple biopsies and imaging
- •No prior breast cancer
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status not specified
- •ECOG performance status 0-1
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine normal
- •Calcium ≤ 3 mmol/L
- •Bilirubin normal
- •ALT and AST ≤ 2.5 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- •No QTc prolongation (defined as a QTc interval ≥ 500 msec) or other significant ECG abnormalities
- •No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •No prior or concurrent NYHA class II-IV cardiovascular disease
- •No inadequately controlled hypertension (systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
- •No myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
- •No pulmonary embolism within the past 12 months
- •No cerebrovascular accident or transient ischemic attack within the past 12 months
- •No serious illness or medical condition that would preclude study compliance including, but not limited to, the following:
- •History of significant neurologic or psychiatric disorder
- •Active uncontrolled infection
- •Serious or nonhealing wound, ulcer, or bone fracture
- •No medical condition that could interfere with oral medication intake (e.g., frequent vomiting, malabsorption)
- •No history of allergic reactions attributed to compounds with similar chemical composition to sunitinib malate
- •No preexisting hypothyroidism unless patient is euthyroid on medication
- •PRIOR CONCURRENT THERAPY:
- •At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:
- •Azole antifungals (ketoconazole, miconazole)
- •Verapamil
- •Clarithromycin
- •HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
- •Erythromycin
- •Delavirdine
- •Diltiazem
- •At least 12 days since prior and no concurrent CYP3A4 inducers, including the following:
- •Phenytoin
- •Rifabutin
- •Hypericum perforatum (St. John's wort)
- 另有 15 项未显示
排除标准
- 未提供
结局指标
主要结局
Feasibility
次要结局
- Comparison of tumor metabolic activity pre- and post-treatment
- Nature, severity, and frequency of adverse events
- Activity (response rate)
- Markers of angiogenesis pre- and post-treatment
- Role of both host- and tumor-specific genes pertaining to response and toxicity
- Comparison of tumor vascular parameters pre- and post-treatment
- Comparison of cell death and tumor microcirculation pre- and post-treatment
研究者
研究点 (2)
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