A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma of 1 of the following tumor types:

- 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 not eligible:

- Gastrointestinal stromal tumor

- Chondrosarcoma

- Malignant mesothelioma

- Neuroblastoma

- Osteosarcoma

- Ewing's sarcoma

- Embryonal rhabdomyosarcoma

- Evidence of disease progression

- Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic
disease

- Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed
within 12 months of therapy

- At least 1 measurable lesion with indicator lesions outside of any prior radiation
field

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

- 15 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic

- SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN
if liver metastases are present)

- Bilirubin no greater than 1.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- Ejection fraction at least 40% by MUGA

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No baseline neurotoxicity grade 2 or greater

- No concurrent serious infection

- No psychiatric disorder that would preclude giving informed consent or complying with
study requirements

- No other concurrent severe or uncontrolled medical illness that would preclude study
participation

- No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix,
or any other malignancy for which the patient has been in complete remission and off
all therapy for at least 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent anticancer biologic therapy

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy and recovered

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

- No concurrent radiotherapy

- Localized radiotherapy to a non-indicator lesion for pain relief allowed
provided all other methods of pain control are ineffective

Surgery

- At least 4 weeks since prior major surgery and recovered

Other

- At least 4 weeks since prior myelosuppressive therapy

- At least 4 weeks since prior investigational drugs

- No other concurrent investigational drugs

- No other concurrent anticancer cytotoxic therapy