Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult angiosarcoma, adult epithelioid sarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult rhabdomyosarcoma, adult synovial sarcoma, stage III adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult neurofibrosarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
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
Sites / Locations
- Karl-Franzens-University Graz
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Tom Baker Cancer Centre - Calgary
- Cross Cancer Institute at University of Alberta
- Doctor H. Bliss Murphy Cancer Centre
- Margaret and Charles Juravinski Cancer Centre
- McGill Cancer Centre at McGill University
- Aarhus Universitetshospital - Aarhus Sygehus
- Copenhagen County Herlev University Hospital
- Institut Bergonie
- Centre Leon Berard
- CHU de la Timone
- Medizinische Universitaetsklinik I at the University of Cologne
- Universitatsklinikum Carl Gustav Carus
- Universitaetsklinikum Essen
- Medizinische Hochschule Hannover
- Klinikum der Stadt Mannheim
- Klinikum der Universitaet Muenchen - Grosshadern Campus
- Southwest German Cancer Center at Eberhard-Karls-University
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- University Medical Center Groningen
- Leiden University Medical Center
- Universitair Medisch Centrum St. Radboud - Nijmegen
- University Medical Center Rotterdam at Erasmus Medical Center
- National Cancer Institute - Bratislava
- Vall d'Hebron University Hospital
- Hospital Universitario San Carlos
- Centre Hospitalier Universitaire Vaudois
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
- Leeds Cancer Centre at St. James's University Hospital
- Royal Marsden - London
- University College of London Hospitals
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- Derriford Hospital
- Cancer Research Centre at Weston Park Hospital
- Aberdeen Royal Infirmary
- Edinburgh Cancer Centre at Western General Hospital
- Western Infirmary
- Gartnavel General Hospital