Clinical Trial Details
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NCT02194231 : ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 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

- 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
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