Clinical trial NCT00410462 (phase 2, status: unknown status)
Conditions: ovarian cancer, sarcoma, small intestine cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32, C17.9, C78.4, D37.2, C17.8, D13.30, D13.39, Z12.13
Drugs: brostallicin, doxorubicin hydrochloride
SMILES: CN1C=C(NC(=O)C2=CC(NC(=O)C3=CC(NC(=O)C4=CC(NC(=O)C(Br)=C)=CN4C)=CN3C)=CN2C)C=C1C(=O)NCCNC(N)=N, 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
Eligibility criteria:

        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