EUCTR2009-014293-17-BE进行中（未招募）1 期
Phase II study of cetuximab combined with cisplatin or carboplatin/pemetrexed as first line treatment in patients with malignant pleural mesothelioma.
niversity Hospital Ghent0 个研究点目标入组 18 人开始时间: 2009年7月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- •- Histological proven malignant pleural mesothelioma, epitheloid subtype
- •- Recurrent after radical surgery or disease not considered suitable for radical treatment
- •- EGFR IHC + as assessed by DAKO kit with at least 1% of cells showing staining
- •- Performance status WHO 0 or 1
- •- Life expectancy > 12 weeks
- •- Weight loss < 10% in last 3 months
- •- Adequate bone marrow reserve (ANC count > 1.5 x 109 /L, platelets > 100 x 109/L)
- •- Creatinine clearance: > 60 mL/min (Cockroft and Gault) or > 50 mL/min (51Cr-EDTA)
- •- Adequate hepatobiliary function (ALT/AST) < 2.5 x upper limit of normal range (ULN) or < 5 x ULN for patients with liver metastases, bilirubin < 1.5 x ULN)
- •- Measurable disease (modified RECIST, see Section X on evaluation of response)
- •- No prior chemotherapy
- •- No prior or other malignancies, except if longer than 5 yrs ago and adequately treated or basocellular skin or in situ cervical cancer
- •- No uncontrolled infection
- •- 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
- •- Written informed consent according to ICH/GCP, and national/local regulations
- •- age of 18 years or older
- •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
- •- Evidence of brain or leptomeningeal metastases
- •- Patients with pre-existing peripheral neuropathy
- •- Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs, for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long acting agents such as piroxicam).
- •- Patients that cannot be treated with folic acid and vit B 12
- •- Patients that cannot be treated with dexamethasone.
- •- Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry.
- •- Use of investigational drugs
- •- Female patients who are lactating or child bearing potential without adequate contraceptive measures
研究者
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