ATREUS TRIALA PHASE II STUDY ON THE ACTIVITY OF TRABECTEDIN IN PRETREATED EPITHELIOID OR BIPHASIC/SARCOMATOID MALIGNANT PLEURAL MESOTHELIOMA (MPM) - ATREUS Study

Istituto di ricerche farmacologiche Mario Negri0 个研究点目标入组 145 人开始时间: 2013年2月26日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•Cytological or histological diagnosis of unresectable MPM;
•age >18 years;
•Performance status 0-2 (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;
•atients must have recovered from toxicities of prior treatment (grade = 1), life expectancy >3 months;
•written informed consent;
•negative pregnancy test.
•Patients who have received palliative radiation are eligible if <30% of bone marrow was irradiated and normal hematological function was completely regained.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•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;
•pregnant or breast-feeding women;
•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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