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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.
UZ Antwerpen
Antwerp, Belgium
University Hospital Ghent
Ghent, Belgium
AZ St. Maarten
Mechelen, Belgium
AMC Heerlen
Heerlen, Netherlands
Progression fee survival rate
Time frame: At 18 weeks
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
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