EUCTR2012-001020-35-NO进行中（未招募）不适用
A randomized phase II trial comparing bevacizumab monotherapy with dacarbazine (DTIC) in treatment of malignant melanoma, focusing on angiogenic markers and prevention of hypertension.
Helse Bergen HF, Haukeland University Hospital0 个研究点开始时间: 2012年9月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Previously treated or untreated histologically confirmed metastatic and unresectable melanoma with radiological (RECIST), clinical or biochemical progressive disease
- •- No previous DTIC
- •- No previous anti-VEGF targeted therapies
- •- WHO performance status 0-1
- •- Age >18 years,
- •- No pregnant or lactating patients can be included.
- •- 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
- •- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 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 dexametasone 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
- •- No clinical evidence of coagulopathy
- •- No unstable angina pectoris
- •- Before patient registration/randomization, written informed consent must be given according to national and local
- •- 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 regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Propranolol contraindications:
- •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
- •- Enalapril contraindications:
- •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
研究者
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