Overview

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

Status:
Completed
Trial end date:
2019-12-12
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether trabectedin is effective in the treatment of malignant pleural mesothelioma (MPM).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborator:
PharmaMar
Treatments:
Trabectedin
Criteria
Inclusion Criteria:

1. Histologically proven unresectable MPM. In order to make a reproducible diagnosis, in
particular regarding biphasic MPM, histology must derive from transthoracic biopsies
(at least 3 representative samples) or from videothoracoscopy (at least 5
representative samples)

2. Age >18 years

3. Performance status 0-1 (ECOG)

4. Measurable disease (CT-PET) according to RECIST criteria modified for malignant
pleural mesothelioma

5. Not more than one previous chemotherapy course (consisting of pemetrexed plus platinum
derivative), excluded adjuvant therapy if PFS < 12 months

6. A minimum of 3 weeks since previous tumour directed therapy

7. Recovery from toxic effects of previous therapies to NCI CTC AE Grade 0-1

8. Patients who have received palliative radiation are eligible if <30% of bone marrow
was irradiated and normal haematological function was completely regained

9. Haematologic variables: haemoglobin ≥ 9 g/dL, Absolute neutrophil count (ANC) ≥
1,500/μL and Platelet count ≥ 100,000/μL

10. Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥ 30 mL/min

11. Creatinine phosphokinase (CPK) ≤ 2.5 ULN

12. Hepatic function variables: Total bilirubin ≤ ULN, Total alkaline phosphatase ≤ 2.5
ULN or if > 2.5 ULN alkaline phosphatase liver fraction or GGT or 5' nucleotidase must
be determined and ≤ ULN, AST (serum aspartate transaminase [SGOT]) and ALT (serum
alaninetransaminase [SGPT]) must be ≤ 2.5 x ULN, Albumin ≥ 25 g/L

13. Signed informed consent

14. 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:

1. - Radiotherapy with curative intent to thoracic wall (concomitant with or prior to
chemotherapy)

2. - Uncompensated diabetes mellitus or other condition absolutely contra-indicating
dexamethasone (used as pre-medication)

3. - Patients enrolled in other study with experimental drugs

4. - Women of childbearing age/potential

5. - Prior exposure to trabectedin

6. - History of other malignancies (except basal cell carcinoma or cervical carcinoma in
situ, adequately treated), unless in remission from 5 years or more and judged of
negligible potential of relapse

7. - Active viral hepatitis or chronic liver disease

8. - Unstable cardiac condition, including congestive heart failure or angina pectoris,
myocardial infarction within one year before enrolment, uncontrolled arterial
hypertension or arrhythmias

9. - Active major infection

10. - Other serious concomitant illness

11. - Brain / leptomeningeal involvement