Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma (NCT00041249) | Clinical Trial Compass
CompletedPhase 2
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Belgium, France64 participantsStarted 2002-05
Plain-language summary
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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
Who can participate
Age range15 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
* Stratum I
* Malignant fibrous histiocytoma
* Liposarcoma
* Rhabdomyosarcoma
* Synovial sarcoma
* Malignant paraganglioma
* Fibrosarcoma
* Leiomyosarcoma
* Angiosarcoma including hemangiopericytoma
* Malignant peripheral nerve sheath tumor
* Unclassified sarcoma
* Miscellaneous sarcoma
* Stratum II
* Gastrointestinal stromal tumor
* Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression
* The following sarcoma types are excluded:
* Mixed mesodermal tumors of the uterus (and carcinosarcoma)
* Chondrosarcoma
* Malignant mesothelioma
* Neuroblastoma
* Osteosarcoma
* Ewing's sarcoma
* Embryonal rhabdomyosarcoma
* At least one measurable lesion
* Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease
* Clinical evidence of progression within 6 weeks prior to study treatment
* No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age:
* Over 15
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 1.25 times upper limit of normal (ULN)
* SGPT and SGOT no greater than 3 times…
Trial details
NCT IDNCT00041249
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC