A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma. (MesoMab)
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.|
- Progression fee survival rate [ Time Frame: At 18 weeks ] [ Designated as safety issue: No ]
- Response rate according to modified RECIST criteria [ Time Frame: every 6 weeks until progression ] [ Designated as safety issue: No ]
- Toxicity (CTCAE version 4) [ Time Frame: weekly during treatment and follow-up of AE's until 30 days after last dosis ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: average survival of 9 - 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: Cetuximab (Erbitux)||
Drug: Cetuximab (Erbitux)
Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.
|Contact: Veerle Surmont, MDfirstname.lastname@example.org|
|Principal Investigator: Dr. Germonprez|
|University Hospital Ghent||Recruiting|
|Ghent, Belgium, 9000|
|Contact: Veerle Surmont, MD email@example.com|
|Principal Investigator: Veerle Surmont, MD|
|AZ St. Maarten||Recruiting|
|Mechelen, Belgium, 2800|
|Contact: Lambrechts, MD|
|Principal Investigator: Lambrechts, MD|
|Principal Investigator: Dr. Bootsma|
|Principal Investigator:||Veerle Surmont, MD||University Hospital, Ghent|