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

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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