Clinical trial NCT00061984 (phase 3, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: doxorubicin hydrochloride, ifosfamide
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, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed soft tissue sarcoma

               -  Locally advanced unresectable* OR metastatic disease

               -  High-grade (grade 2-3) disease according to the FNLCC grading system NOTE:
                  *Disease that could prove resectable (including pulmonary metastasectomy) after a
                  response to chemotherapy is allowed

          -  The following tumor types are eligible:

               -  Malignant fibrous histiocytoma

               -  Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated
                  liposarcoma

               -  Pleomorphic rhabdomyosarcoma

               -  Synovial sarcoma

               -  Myxofibrosarcoma, intermediate and high-grade

               -  Fibrosarcoma

               -  Leiomyosarcoma

               -  Angiosarcoma

               -  Malignant peripheral nerve sheath tumor

               -  Epithelioid sarcoma

               -  Alveolar rhabdomyosarcoma

               -  Unclassifiable sarcoma, not otherwise specified

          -  The following tumor types are not eligible:

               -  Gastrointestinal stromal tumor

               -  Mixed mesodermal tumor

               -  Chondrosarcoma

               -  Malignant mesothelioma

               -  Neuroblastoma

               -  Osteosarcoma

               -  Ewing's sarcoma/primitive neuroectodermal tumor

               -  Desmoplastic small round cell tumor

               -  Embryonal rhabdomyosarcoma

               -  Alveolar soft part sarcoma

          -  Must have a measurable lesion with clinical evidence of progression within the past 6
             weeks

               -  Osseous lesions and pleural effusions are not considered measurable

          -  No known or symptomatic CNS metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 60

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 2,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.8 mg/dL

          -  Albumin at least 2.5 g/dL

        Renal

          -  Creatinine no greater than 1.4 mg/dL OR

          -  Creatinine clearance greater than 65 mL/min

        Cardiovascular

          -  No history of cardiovascular disease

        Other

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other severe medical illness

          -  No psychosis

          -  No other prior or concurrent malignancy except adequately treated carcinoma in situ of
             the cervix or basal cell skin cancer

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance and follow-up schedule

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for advanced or metastatic disease

          -  Prior adjuvant chemotherapy allowed provided there was no disease progression within 6
             months after completion of treatment

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to the sole index lesion

        Surgery

          -  Not specified