Status:
COMPLETED
ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
PharmaMar
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether trabectedin is effective in the treatment of malignant pleural mesothelioma (MPM).
Detailed Description
There are no approved agents for second-line treatment of MPM in patients who failed first line pemetrexed plus platinum derivatives regimens. Chemotherapy options are limited and include gemcitabine,...
Eligibility Criteria
Inclusion
- 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)
- Age \>18 years
- Performance status 0-1 (ECOG)
- Measurable disease (CT-PET) according to RECIST criteria modified for malignant pleural mesothelioma
- Not more than one previous chemotherapy course (consisting of pemetrexed plus platinum derivative), excluded adjuvant therapy if PFS \< 12 months
- A minimum of 3 weeks since previous tumour directed therapy
- Recovery from toxic effects of previous therapies to NCI CTC AE Grade 0-1
- Patients who have received palliative radiation are eligible if \<30% of bone marrow was irradiated and normal haematological function was completely regained
- Haematologic variables: haemoglobin ≥ 9 g/dL, Absolute neutrophil count (ANC) ≥ 1,500/μL and Platelet count ≥ 100,000/μL
- Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥ 30 mL/min
- Creatinine phosphokinase (CPK) ≤ 2.5 ULN
- 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
- Signed informed consent
- 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
- \- Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy)
- \- Uncompensated diabetes mellitus or other condition absolutely contra-indicating dexamethasone (used as pre-medication)
- \- Patients enrolled in other study with experimental drugs
- \- Women of 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 from 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 illness
- \- Brain / leptomeningeal involvement
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2019
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT02194231
Start Date
July 1 2013
End Date
December 12 2019
Last Update
January 23 2020
Active Locations (8)
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1
Azienda ospedaliera ss. Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
2
Cliniche Humanitas Gavazzeni
Bergamo, BG, Italy
3
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Bo, Italy, 40138
4
P.O. Spedalli Civili
Brescia, BS, Italy, 25125