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.
|First Received Date||October 15, 2009|
|Last Changed Date||February 7, 2017|
|Start Date||October 2009|
|Actual Primary Completion Date||September 2015|
|Primary Outcome Measures||
Progression fee survival rate [Time Frame: At 18 weeks]
|Secondary Outcome Measures||
Response rate according to modified RECIST criteria [Time Frame: every 6 weeks until progression]
Toxicity (CTCAE version 4) [Time Frame: weekly during treatment and follow-up of AE's until 30 days after last dosis]
Overall survival [Time Frame: average survival of 9 - 12 months]
|Study Arms / Comparison Groups||1 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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.
- > 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
|Sponsor||University Hospital, Ghent|
|Verification Date||February 2017|