NCT01705392终止2 期
A Randomized Phase II Trial Comparing Bevacizumab Monotherapy With Dacarbazine (DTIC) in Treatment of Malignant Melanoma, Focusing on Angiogenic Markers and Prevention of Hypertension.
Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to evaluate the predictive value of a set biomarkers associated with vascular endothelial growth factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing acquired resistance to treatment with bevacizumab and escape mechanisms caused by other angiogenic growth factors than VEGF. Finally, we want to analyze safety and influence on outcome variables by primary prevention of bevacizumab induced hypertension by low dose beta blockers in comparison with an ACE inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Previously treated or untreated, histologically confirmed, metastatic and unresectable melanoma with progressive disease
- •Both BRAF wild type patients as well as BRAF mutated patients are allowed. For BRAF mutated patients, BRAF targeting agents should be considered in first line if otherwise indicated and no contraindications exist.
- •WHO performance status 0-1
- •Age >18 years,
- •Known BRAF mutation
- •Able to undergo outpatient treatment
- •Patients must have clinically and/or radiographically documented measurable disease according to RECIST.
- •All radiology studies must be performed within 28 days prior to registration (35 days if negative).
- •At least 4 weeks since adjuvant interferon alpha
- •At least 4 weeks since 1st line treatment in case of metastasis
- •Major surgical procedure or significant traumatic injury > 28 days prior to study treatment start. Biopsy or fine needle aspiration > 2 days prior to study treatment start. Central venous line placement must be inserted at least 2 days prior to treatment start.
- •Only patients with irradiated and asymptomatic brain metastases and off dexamethasone are allowed.
- •Hematology: absolute granulocytes > 1.0 x 109/L
- •Platelets > 100 x 109/L
- •Bilirubin < 1.5 x upper normal limit
- •Serum creatinine < 1.5 x upper normal limits
- •LDH < 1.5 x upper normal limit
- •INR < 1.5
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Before patient registration/randomization, written informed consent must be given according to national and local regulations.
排除标准
- •No previous DTIC
- •No previous anti-VEGF targeted therapies
- •No pregnant or lactating patients can be included
- •No clinical evidence of coagulopathy
- •No unstable angina pectoris
- •No AV-block II or III without pacemaker
- •No severe congestive heart failure
- •No untreated phaeochromocytoma
- •No severe bradycardia
- •No severe hypotension
- •No severe impairment of peripheral arterial circulation
- •No uncontrolled cardiac arrhythmia
- •No severe asthma or COPD
- •No uncontrolled diabetes mellitus
- •No Angioneurotic edema
- •No severe Aortic valve stenosis
- •No severe hypertrophic cardiomyopathy
- •No severe renal dysfunction
- •No patients on beta blockers/ ACE inhibitors by inclusion unable/unwilling to discontinue beta blockers/ ACE inhibitors and convert to other classes of antihypertensive drugs
- •No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day).
- •No uncontrolled hypertension
研究组 & 干预措施
Bevacizumab plus enalapril
Experimental
Bevacizumab 10mg/kg q2w plus enalapril 5 mg x 1
干预措施: Bevacizumab (Drug)
Bevacizumab plus propranolol
Experimental
Bevacizumab 10mg/kg q2w plus propranolol 80 mg x 1
干预措施: Bevacizumab (Drug)
Bevacizumab plus propranolol
Experimental
Bevacizumab 10mg/kg q2w plus propranolol 80 mg x 1
干预措施: Propranolol (Drug)
Bevacizumab plus enalapril
Experimental
Bevacizumab 10mg/kg q2w plus enalapril 5 mg x 1
干预措施: Enalapril (Drug)
Dacarbazine
Active Comparator
Dacarbazine 1000mg/m2 q3w
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Progression free survival
时间窗: Average of 6 months
Participants will be followed for the duration of the treatment and as long as they do not progress, an expected average of 6 months
次要结局
- Response Rates according to RECIST(Average 6 months)
- Overall survival(Average og 12 months)
- Disease control rate at 6 months(6 months)
- Prevention of hypertension by beta blockers or ACE-inhibitors(Average of 6 months)
研究者
研究点 (1)
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