Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Progression fee survival rate
研究概览
简要总结
Multicenter, open phase 2 study on patients with malignant mesothelioma. Standardly, 4 to 6 cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given. Despite of this treatment, median survival is poor (9-12 months). By combining conventional cytotoxic agents with a novel agent, hopefully treatment and survival can be approved. Cetuximab or Erbitux is a monoclonal antibody against the EGFR (Epidermal Growth Factor Receptor). By blocking the receptor, it interferes with cel growth and division. Most mesothelioma show a strong expression of the EGFR protein. Apart from that, Cetuximab also has antibody-dependent cell-mediated cytotoxicity (ADCC).
In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be continued until disease progression. Every 6 weeks, a CT scan will be done to evaluate therapy. Most common side effect of Cetuximab is acneiform rash.
The translation research program consists of the determination of EGFR- and K-Ras mutations on the tumor tissue and the correlation with outcome.
In the first part of the trial, 18 patients will be included. After a positive interim analysis, a total of 43 patients will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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
排除标准
- •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
研究组 & 干预措施
Cetuximab (Erbitux)
干预措施: Cetuximab (Erbitux) (Drug)
结局指标
主要结局
Progression fee survival rate
时间窗: At 18 weeks
次要结局
- Toxicity (CTCAE version 4)(weekly during treatment and follow-up of AE's until 30 days after last dosis)
- Response rate according to modified RECIST criteria(every 6 weeks until progression)
- Overall survival(average survival of 9 - 12 months)