NCT00416637已完成1 期
Biomarker and Clinical Evaluation of Bevacizumab (Avastin) to Determine the Role of Nitric Oxide in Anti-VEGF Therapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor .
PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine whether anti-vascular epidermal growth factor (VEGF) treatment comprising bevacizumab causes changes in endothelial cell function, as measured by brachial reactivity, and changes in nitric oxide (NOx), as measured by plasma/urinary/exhaled NOx levels, in patients with advanced solid tumors.
- Determine whether anti-VEGF-related changes in blood pressure correlate with changes in brachial reactivity and NOx levels.
Secondary
- Evaluate anti-angiogenic effects of bevacizumab in neovascular tissue in the wound angiogenesis model.
- Correlate inhibition of wound angiogenesis with changes in VEGF-receptor 2 phosphorylation status and changes in NOx synthase expression.
- Describe the mean and associated variability of other plasma and urine markers known to be associated with vascular reactivity, endothelial function, and/or tumor angiogenesis.
- Describe, preliminarily, whether these changes correlate with changes in blood pressure, brachial reactivity, NOx levels, or wound angiogenesis.
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 solid tumor
- •Metastatic or unresectable disease
- •Standard curative or palliative measures do not exist or are no longer effective OR treatment with standard chemotherapy plus bevacizumab is appropriate* NOTE: *It must be judged clinically appropriate by the treating physician to delay combination treatment for the 6 weeks needed for study participation
- •Patients with squamous cell non-small cell lung cancer are ineligible
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 2,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9.0 g/dL
- •AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases are present)
- •Creatinine clearance ≥ 50 mL/min
- •No proteinuria at baseline
- •Patients with ≥ 1+ proteinuria during screening should undergo a timed 12- or 24-hour urine collection, which must be an adequate collection and must demonstrate < 500 mg protein/24 hr to be eligible for the study
- •Not pregnant or nursing
- •No nursing for ≥ 4 months after completion of study treatment
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 4 months after completion of study treatment
- •No arterial thromboembolic events within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •Clinically significant peripheral vascular disease
- •No venous thromboembolic event within the past 3 months
- •No clinically significant cardiovascular disease
- •No uncontrolled hypertension
- •No New York Heart Association class II or greater congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •Atrial or supraventricular tachycardias that are well controlled with beta blockers or calcium channel blockers are allowed
- •Chronic pacemakers allowed
- •No presence of bleeding diathesis or coagulopathy
- •No significant traumatic injury within the past 4 weeks
- •No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
- •PRIOR CONCURRENT THERAPY:
- •No administration of nitrates within the past week
- •At least 2 weeks since prior and no concurrent antihypertensive agent(s)
- •Must have stable blood pressure (BP) (BP < 160/100 mm Hg) within the past 2 weeks
- •Must be asymptomatic within the past 2 weeks
- •No open biopsy within the past 14 days
- •No fine needle aspirations other than in the breast within the past 7 days
- •No placement of a vascular access device within the past 7 days
- •No major surgical procedure within the past 4 weeks
- •No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) and recovered
- •No radiotherapy within the past 4 weeks
- •No previous treatment with bevacizumab
- •No need for major surgical procedure during the course of the study
- •No other cancer immunotherapy or biologic therapy while on the study
- •No concurrent or recent (within past 10 days) use of full-dose oral or parenteral anticoagulants (heparin > 10,000/day or an INR > 1.5) or thrombolytic agents
- •1 mg of warfarin is permitted as required to maintain patency of preexisting, permanent indwelling IV catheters
- 另有 1 项未显示
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab (Avastin)
Experimental
Bevacizumab given and then BP checked and skin biopsies obtained.
干预措施: Bevacizumab (Avastin) (Biological)
研究者
Herbert Hurwitz, MD
Associate Professor of Medicine
Duke University
相似试验
已完成
不适用
TC Avastin. ICORG 08-10, V6Breast CancerNCT00911716Cancer Trials Ireland106
已完成
2 期
Bevacizumab in Treating Patients With Recurrent or Progressive GliomaBrain and Central Nervous System TumorsNCT00337207Northwestern University55
已完成
1 期
Bevacizumab in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsLeukemiaNCT00022048Stanford University
已完成
2 期
Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck CancerHead and Neck CancerNCT00281840Case Comprehensive Cancer Center30
已完成
1 期
N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk NeuroblastomaNeuroblastomaNCT00885326New Approaches to Neuroblastoma Therapy Consortium29