Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

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.

OBJECTIVES:

* Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
* Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).

Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Eligibility Criteria:
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/min

Cardiovascular:

* No history of severe cardiovascular disease

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 6 months after study participation
* No other severe medical illness, including psychosis
* No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No other concurrent cytotoxic therapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No radiotherapy to the sole measurable lesion
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
* No other concurrent anticancer therapy