From the blog

ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)

Published: July 30, 2014


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
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