Phase II study of Cetuximab combined with Cisplatin or Carboplatin/Pemetrexed as first line treatment in patients with malignant pleural mesothelioma - MesoMab

Atrium MC Heerlen0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Histologically 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, renal and hepatic function
•- Measurable disease (modified RECIST)
•- 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
•- Written informed consent.
•- Male/Female
•- > 18 years

•- Evidence of brain or leptomeningeal metastases
•- Patients who are unable to interrupt aspirin, 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 vitamin B 12
•- Patients that cannot be treated with dexamethasone.
•- Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites of pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry.
•- Use of investigational drugs
•- Pregnant or lactating women

发起方

Atrium MC Heerlen