Primary Outcome Measure:
- Progression Free Survival (PFS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Eligibility Criteria
- Inclusion Criteria:
-
- Cytological or histological diagnosis of unresectable MPM
- Age > 18 years
- Performance status 0-1 (ECOG)
- Measurable disease (CT-PET)
- Normal bone marrow reserve
- Adequate liver and renal function
- Not more than one previous chemotherapy course (of pemetrexed plus platinum derivative)
- Previous chemotherapy course concluded at least 3 weeks prior to recruitment
- Patients must have recovered from toxicities of prior treatment (grade ≤ 1)
- Life expectancy >3 months
- Written informed consent
- Patients who have received palliative radiation are eligible if <30% of bone marrow was irradiated and normal hematological function was completely regained
- Adequate contraceptive methods for male patients whose partner is of childbearing age/potential, during the study and for three months after the end of treatment
- Exclusion Criteria:
-
- Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy)
- Adjuvant chemotherapy; severe concomitant illness
- Uncompensated diabetes mellitus or other condition absolutely contra-indicating dexamethasone (20 mg, used as pre-medication)
- Enrollment in other trials
- Female patients in childbearing age/potential
- Prior exposure to trabectedin; history of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated)
- Unless in remission for 5 years or more and judged of negligible potential of relapse
- Active viral hepatitis or chronic liver disease
- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
- Active major infection
- Other serious concomitant illnesses
- Brain / leptomeningeal involvement
