From the blog

A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma. (MesoMab)

Published: October 15, 2009

Primary Outcome Measures:

  • Progression fee survival rate [ Time Frame: At 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • 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 ]

Eligibility Criteria

Inclusion Criteria:
  • 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.
  • Male/Female
  • > 18 years
Exclusion Criteria:
  • 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
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