EUCTR2010-022104-50-NL进行中（未招募）不适用
A randomized phase II study of paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV non-squamous-non-small cell lung cancer: NVALT12 - NVALT12
Stichting NVALT Studies0 个研究点目标入组 222 人开始时间: 2010年7月30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
- 入组人数
- 222
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
- •Histologically/cytologically proven stage IV non-squamous NSCLC (according to IASLC staging 7.0)
- •No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized palliative irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. Prior adjuvant chemotherapy > 1 year ago and prior treatment with an EGFR-TKI for patients with an activating EGFR mutation is allowed.
- •Age = 18 years.
- •ECOG Performance Status of 0 – 2.
- •Life expectancy of at least 12 weeks.
- •Subjects with at least one uni-dimensional(for RECIST) measurable lesion.
- •Adequate bone marrow, liver and renal function (see protocol for details).
- •Adequate non-hormonal contraception for females of childbearing potential during the study and in the 6 months thereafter.
- •Adequate contraception for male participants (or their partners) during the study and in the 6 months thereafter.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 150 mmHg and/or diastolic > 100 mmHg).
- •Symptomatic hypotension.
- •History of hemoptysis at least grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
- •Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery).
- •History of HIV infection or chronic hepatitis B or C.
- •Active clinically serious infection
- •Symptomatic metastatic brain or meningeal tumors. Patients with brain metastasis may be included the patient is treated with brain radiotherapy and asymptomatic.
- •History of organ allograft.
- •Patients with evidence or history of bleeding diathesis.
- •Non-healing wound or ulcer.
- •History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
- •Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
- •Radiotherapy within 4 weeks of start of study drug. Palliative radiotherapy for bone lesions is allowed > 14 days of start of chemotherapy. Major surgery within 4 weeks of start of study.
- •Use of vasodilators (including 5-fosfodiesterase inhibitors, calcium antagonists or nitrates)
- •Autologous bone marrow transplant or stem cell rescue within 4 months of study
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •Pregnancy or lactation.
研究者
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