Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

Inclusion Criteria: * Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated) * Pathology specimens available for centralized review * Age ≥ 18 years * European Eastern Cooperative Oncology Group Personal Status (ECOG PS) ≤ 2 * One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated) * Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST) * A minimum of 3 weeks since any previous medical therapy * Recovery from toxic effects of prior therapies to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 1 or lower * Adequate haematological, renal and liver functions * Ability and willingness to provide informed consent Exclusion Criteria: * Pregnant or breast-feeding women * Prior exposure to trabectedin * Peripheral neuropathy, Grade 2 or higher * History of other malignancies (except for 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 * Known central nervous system (CNS) metastases * 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 …