Cancer Clinical Trial
Official title:
Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
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.
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