NCT00734890已完成1 期
Phase I Study of Vandetanib (ZD 6474) and Bevacizumab Combination Therapy Evaluating the VEGF and EGF Signal Transduction Pathways in Adults With Solid Tumors and Lymphomas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Vandetanib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving vandetanib together with bevacizumab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and bevacizumab in treating patients with advanced solid tumors or lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose, safety, and toxicity of vandetanib and bevacizumab in patients with advanced solid tumors or lymphoma.
Secondary
- Characterize the pharmacokinetic profile of this regimen in these patients.
- Measure changes in VEGF and other angiogenic cytokines in plasma samples from these patients.
- Determine the biochemical changes in the EGF signal transduction pathways in tumor biopsy samples from these patients.
- Determine the anti-angiogenic effects of this regimen in tumor biopsy samples from these patients.
- Evaluate the application of dynamic contrast-enhanced MRI to determine early changes in tumor vascular permeability during treatment.
- Evaluate the effects of this regimen on circulating endothelial progenitors and mature circulating endothelial cells in these patients.
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:
- •Histologically confirmed advanced malignancy, including the following:
- •Solid tumor that is refractory to standard therapy or for which no standard therapy exists
- •No lung carcinoma of squamous cell or small cell histology (mixed tumors will be categorized by the predominant cell type)
- •Histological confirmation based on sputum cytology alone is not acceptable
- •Lymphoma (Hodgkin or non-Hodgkin lymphoma) that has progressed after standard therapy AND for which stem cell transplantation is not indicated or has been refused
- •No known CNS disease, except for treated brain metastasis meeting the following criteria:
- •No ongoing requirement for steroids
- •No evidence of progression or hemorrhage by clinical examination and brain imaging (MRI or CT scan) for ≥ 3 months after treatment
- •Stable dose of anticonvulsants allowed
- •Prior treatment for brain metastases may have included whole-brain radiotherapy, radiosurgery (gamma knife, linear accelerator, or equivalent), or a combination of therapy as deemed appropriate by the treating physician
- •Neurosurgical resection or brain biopsy for treatment of CNS metastases allowed provided treatment was completed more than 3 months ago
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy > 3 months
- •Absolute neutrophil count ≥ 1,500/μL
- •Platelet count ≥ 100,000/μL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- •Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
- •Activated partial thromboplastin time ≤ 1.5 times ULN
- •Prothrombin time OR INR < 1.5 times ULN
- •Potassium between 4 mmol/L and ULN (supplementation allowed)
- •Magnesium normal (supplementation allowed)
- •Serum calcium (adjusted for albumin) or ionized calcium normal (supplementation allowed)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
- •HIV-positivity allowed provided the following criteria are met:
- •Patient does not require anti-HIV therapy
- •CD4 count > 350/mm^3
- •HIV viral load < 25,000 copies/mm^3
- •No history of opportunistic infections
- •No evidence of severe or uncontrolled systemic disease or any concurrent condition that could compromise participation in the study, including any of the following:
- •Active or uncontrolled infection
- •Immune deficiencies
- •HIV infection requiring anti-HIV therapy
- •Hepatitis B
- •Hepatitis C
- •Uncontrolled diabetes
- •Uncontrolled hypertension
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Myocardial infarction within the past 6 months
- •Uncontrolled cardiac arrhythmia
- •Stroke/cerebrovascular accident within the past 6 months
- •Psychiatric illness/social situation that, in the investigator's opinion, would make it undesirable for the patient to participate in the study or that would jeopardize study compliance
- •No New York Heart Association class III or IV heart disease within the past 6 months
- •No history of arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment
- 另有 34 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
Safety
Toxicity
次要结局
未报告次要终点
研究者
研究点 (2)
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