RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
Who can participate
Age range15 Years – 75 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma
* Malignant fibrous histiocytoma
* Liposarcoma
* Rhabdomyosarcoma
* Synovial sarcoma
* Malignant paraganglioma
* Fibrosarcoma
* Leiomyosarcoma
* Angiosarcoma including hemangiopericytoma
* Malignant peripheral nerve sheath tumor
* Unclassified sarcoma
* Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
* The following tumor types are excluded:
* Gastrointestinal stromal tumor
* Chondrosarcoma
* Malignant mesothelioma
* Neuroblastoma
* Osteosarcoma
* Ewing's sarcoma
* Embryonal rhabdomyosarcoma
* Prior chemotherapy for metastatic disease required
* One line of combination chemotherapy containing anthracycline OR
* No more than 2 single-agent regimens including anthracycline
* Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
* Must have 1 measurable lesion
* Clinical evidence of progression within 6 weeks prior to study
* Osseous lesions and pleural effusions not considered measurable
* No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 15 to 75
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/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/…
Trial details
NCT IDNCT00041236
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC