Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
Inclusion Criteria
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 ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance greater than 65 mL/min
Cardiovascular:
- No prior severe cardiovascular disease
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 6 months after
study
- No other prior or concurrent malignancy except adequately treated basal cell skin
cancer or carcinoma in situ of the cervix
- No other severe medical illness
- No psychosis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic response modifiers or immunotherapy
- No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or
sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy and recovered
- Prior adjuvant chemotherapy as first-line treatment allowed provided disease
progressed within 6 months after the completion of chemotherapy
- No prior ecteinascidin 743 (stratum I)
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to sole measurable lesion
- Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's
discretion
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- No other concurrent anticancer therapy (approved or investigational)
- No concurrent participation in any other clinical treatment study
- No other concurrent investigational drugs