ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)
Conditions
Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
Mesothelioma, MPM, Trabectedin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Trabectedin
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine whether trabectedin is effective in the treatment of malignant pleural mesothelioma (MPM).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Azienda ospedaliera ss. Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
Status: Recruiting
Contact: Federica Grosso, MD - fgrosso@ospedale.al.it
Cliniche Humanitas Gavazzeni
Bergamo, BG, Italy
Status: Recruiting
Contact: Giovanni L Ceresoli, MD - giovanni_luca.ceresoli@gavazzeni.it
P.O. Spedalli Civili
Brescia, BS, Italy
Status: Recruiting
Contact: Gianfranco MD Tassi
Azienda Ospedaliera S. Gerardo di Monza
Monza, MB, Italy
Status: Recruiting
ASL VC
Vercelli, VC, Italy
Status: Recruiting
Contact: Luciano MD Mutti
Start Date
July 2013
Completion Date
October 2016
Sponsors
Mario Negri Institute for Pharmacological Research
Source
Mario Negri Institute for Pharmacological Research
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page