Clinical trial NCT01104298 (phase 2, status: terminated)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: doxorubicin, trabectedin
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, [H][C@@]12[C@@H]3SC[C@]4(NCCC5=C4C=C(OC)C(O)=C5)C(=O)OC[C@H](N1[C@@H](O)[C@@H]1CC4=CC(C)=C(OC)C(O)=C4[C@H]2N1C)C1=C2OCOC2=C(C)C(OC(C)=O)=C31
Reason stopped: 
    interim analysis did not show good results for main objective
  
Eligibility criteria:

        Inclusion Criteria:

          -  The patient must sign voluntarily the informed consent from before any study test is
             conducted that is not part of routine patient care, with the knowledge that he/she can
             abandon the study at any time without this affecting his/her previous care.

          -  Aged between 18 and 70.

          -  Pathological diagnosis of non operable and/or metastatic soft tissue sarcoma.

          -  The following histological subtypes can be included:

               -  Undifferentiated pleomorphic sarcoma (previously,malignant fibrous istiocytoma)

               -  Leiomyosarcoma

               -  Angiosarcoma

               -  Liposarcoma

               -  Synovial sarcoma

               -  Fibrosarcoma

               -  Hemangiopericytoma

               -  Neurofibrosarcoma

               -  Mixofibrosarcoma

               -  Unclassified sarcoma

          -  Measurable disease, according to RECIST criteria

          -  Performance status 0-2 Eastern Cooperative Oncology Group(ECOG).

          -  Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3,
             neutrophils ≥1.500/mm3, platelets ≥ 100.000/mm3). Patients with plasma creatinine ≤
             1,6 mg/dL, transaminases ≤2.5 times the upper limit of normal (ULN), total bilirubin ≤
             upper limit of normal (ULN), CPK ≤ 2.5 times upper limit of normal (ULN), alkaline
             phosphatase ≤ 2.5 times the upper limit of normal (ULN) are acceptable. If the
             increase of alkaline phosphatase is > 2.5 times the upper limit of normal (ULN), then
             the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤
             upper limit of normal (ULN).

          -  Men or women of child bearing potential should be using an effective method of
             contraception before entry into the study and throughout the same and for 6 months
             after ending the study. Women of childbearing potential must have a negative urine
             pregnancy test before study entry.

          -  Normal cardiac function with a Left ventricular ejection fraction (LVEF) ≥ 50% by
             echocardiogram or Multiple Uptake Gated Acquisition Scan (MUGA).

        Exclusion Criteria:

          -  Previous chemotherapy treatment.

          -  Previous radiotherapy involving the only localization(s) of measurable tumoral
             disease.

          -  Performance status> 2 Eastern Cooperative Oncology Group(ECOG).

          -  Central Nervous System (CNS) metastases.

          -  Plasma bilirubin > upper limit of normal(ULN).

          -  Creatinine > 1.6 mg/dL.

          -  History of other neoplastic disease with the exception of basalioma or in situ
             cervical cancer adequately treated.

          -  Significant cardiovascular disease (for example, dyspnea > 2 NYHA)

          -  Significant systemic diseases grade 3 or higher on the NCI-CTC version 3.0 scale, that
             limit patient availability, or according to investigator judgment may contribute
             significantly to treatment toxicity.

          -  Uncontrolled bacterial, mycotic or viral infections.

          -  Women who are pregnant or breast-feeding

          -  Psychological, familial, social or geographic circumstances that limit the patient's
             ability to comply with the protocol or informed consent.

          -  Patients participating in another clinical trial or receiving any other
             investigational product.

          -  Patients who had participated in another clinical trial and/or had received any other
             investigational product in the last 30 days prior to inclusion.

          -  The following histologic subtypes are excluded:

               -  Rhabdomyosarcoma

               -  Ewing's family of tumors

               -  Desmoplastic small round cell tumor

               -  Clear cell sarcoma

               -  Alveolar sarcoma