Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed high- or intermediate-grade malignant soft tissue sarcoma\* of 1 of the following cellular types:
• * Adipocytic (e.g., liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, not otherwise specified)
• * Fibroblastic (e.g., adult fibrosarcoma, myxofibrosarcoma, or sclerosing epithelioid fibrosarcoma)
• * So-called fibrohistiocytic (e.g., pleomorphic malignant fibrous histiocytoma \[MFH\], giant cell MFH, or inflammatory MFH)
• * Leiomyosarcoma
• * Malignant glomus tumors
• * Skeletal muscle (e.g., rhabdomyosarcoma, alveolar, or pleomorphic)
• * Vascular (e.g., epithelioid hemangioendothelioma or angiosarcoma)
• * Uncertain differentiation (e.g., synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor \[PEComa\], or intimal sarcoma)
• * Malignant peripheral nerve sheath tumors
• * Malignant solitary fibrous tumors
• * Undifferentiated soft tissue sarcomas not otherwise specified
• * Other types of sarcoma if approved by the study coordinator NOTE: \*Includes malignant tumors of non-organ origin and skin and uterine leiomyosarcoma
• The following tumor types are excluded:
• * Embryonal rhabdomyosarcoma
• * Chondrosarcoma
• * Osteosarcoma
• * Ewing tumors/primitive neuroectodermal tumor (PNET)
• * Gastrointestinal stromal tumors
• * Dermatofibrosarcoma protuberans
• * Inflammatory myofibroblastic sarcoma
• * Neuroblastoma
• * Malignant mesothelioma
• * Mixed mesodermal tumors of the uterus
• Relapsed, refractory, and/or metastatic disease incurable by surgery or radiotherapy
• Measurable disease
• Must have formalin fixed paraffin-embedded tumor blocks and representative hematoxylin/eosin slides available for histological central review
• No symptomatic or known CNS metastases
• PATIENT CHARACTERISTICS:
• At least 60 years of age OR ≥ 18 years of age if patient is not suitable for intensive combination chemotherapy treatments
• WHO performance status 0-1
• Absolute neutrophil count \> 2,000/mm³
• Platelet count \> 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine clearance ≥ 60 mL/min
• No serious cardiac illness within the past 6 months, including, but not limited to the following:
• * History of documented congestive heart failure
• * High-risk uncontrolled arrhythmias
• * Angina pectoris requiring antianginal medication
• * Clinically significant valvular heart disease
• * Evidence of transmural infarction on ECG
• * Poorly-controlled hypertension (e.g., systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 100 mm Hg)
• Normal 12-lead ECG
• LVEF normal by MUGA or echocardiogram
• No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
• No other serious and/or unstable medical condition, illness, or lab abnormality that would preclude study participation
• No psychiatric illness or familial, social, or geographical condition that would preclude study compliance
• No active uncontrolled infection
• No known AIDS positivity
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy regimen for advanced or metastatic disease (neoadjuvant and adjuvant therapy allowed)
• No concurrent sargramostim (GM-CSF) except in cases of febrile neutropenia
• No other concurrent anticancer therapy or investigational agents, including any of the following:
• * Chemotherapy
• * Biological response modifiers
• * Hormone therapy
• * Immunotherapy
• No other concurrent clinical treatment trial participation