A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma. (MesoMab)
|ClinicalTrials.gov Identifier: NCT00996567|
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : February 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Cetuximab (Erbitux)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
|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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996567
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|AZ St. Maarten|
|Mechelen, Belgium, 2800|
|Principal Investigator:||Veerle Surmont, MD||University Hospital, Ghent|