Clinical trial NCT01189253 (phase 2/phase 3, status: terminated)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: doxorubicin hydrochloride, 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: 
    results of step1: none of the experimental arms fulfills expectations and the study will not
    continue as a phase iii.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed intermediate- or high-grade malignant soft tissue sarcoma

               -  Advanced and/or metastatic disease

               -  Previously untreated disease

          -  The following tumor types are not allowed:

               -  Well-differentiated liposarcoma

               -  Embryonal rhabdomyosarcoma

               -  Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)

               -  Osteosarcoma (excluding extraskeletal osteosarcoma)

               -  Ewing tumors/primitive neuroectodermal tumor (PNET)

               -  Gastrointestinal stromal tumors (GIST)

               -  Dermatofibrosarcoma protuberans

          -  Must have confirmed disease progression based on investigator's judgment prior to
             study enrollment

          -  Measurable disease according to RECIST v 1.1 criteria

               -  Tumor lesions situated in a previously irradiated area, or in an area subjected
                  to other loco-regional therapy, are usually not considered measurable unless
                  there has been demonstrated progression in the lesion

          -  Formalin fixed paraffin embedded tumor blocks or representative hematoxylin/eosin
             slides (preferably both) available (local histopathological diagnosis will be accepted
             for trial entry)

          -  No prior anticancer therapy for this disease

               -  No prior anthracycline

               -  Non-anthracycline therapy for nonmetastatic disease is acceptable

          -  No known history of CNS metastases or leptomeningeal tumor spread

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-1

          -  Absolute neutrophil count ≥ 1.5 x 10^9/L

          -  Hemoglobin ≥ 9 g/dL

          -  Platelet count ≥ 100 x 10^9/L

          -  Bilirubin normal

          -  ALT/AST ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN, (if alkaline phosphatase > 2.5 times ULN,
             hepatic isoenzymes 5-nucleotidase and/or GGT must be within the normal range)

          -  Albumin > 30 g/L

          -  Serum creatinine ≤ 1.5 times ULN

          -  Creatinine clearance ≥ 30 mL/min

          -  Creatine phosphokinase (CPK) ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception (double barrier method for men) 2
             weeks prior to, during, and for 3 months (women) or 5 months (men) after completion of
             study therapy

          -  LVEF normal by MUGA scan or ECHO

          -  12-lead ECG normal (without clinically significant abnormalities)

          -  None of the following unstable cardiac conditions:

               -  Congestive heart failure

               -  Angina pectoris

               -  Myocardial infarction within the past year

               -  Uncontrolled arterial hypertension, defined as BP ≥ 150/100 mm Hg despite optimal
                  medical therapy

               -  Clinically significant arrhythmias

          -  No active or uncontrolled infections or serious illnesses or medical conditions,
             including a history of any of the following:

               -  Chronic alcohol abuse

               -  Hepatitis

               -  HIV

               -  Cirrhosis

          -  No history of malignancy within the past 5 years, except soft tissue sarcoma, basal
             cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, resected
             incidental prostate cancer (staged pT2 with Gleason score ≤ 6 and postoperative PSA <
             0.5 ng/mL)

               -  Patients with any history of malignancies who are disease-free for more than 5
                  years are eligible

          -  a history of malignancy and disease-free for more than 5 years

          -  No psychological, familial, sociological, or geographical condition potentially
             hampering compliance with the study protocol and follow-up schedule

          -  No concurrent alcohol consumption

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 28 days since prior and no concurrent anticancer therapy including systemic
             therapy, radiotherapy, or surgery

          -  At least 28 days since prior and no other concurrent investigational agents

          -  No concurrent phenytoin, live attenuated vaccines, or yellow fever vaccine