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

You may be eligible if

• 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