Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

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