Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Soft-Tissue Sarcomas

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic
inoperable soft tissue sarcoma Measurable or evaluable disease that has not been
irradiated Must have received, refused, or be not eligible for doxorubicin/ifosfamide
treatment Previously untreated gastrointestinal leiomyosarcoma allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life
expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL
Cardiovascular: No New York Heart Association class III or IV heart disease No active
coronary disease requiring therapy Pulmonary: No severe pulmonary insufficiency Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 3 months after study No other prior malignancy in past 3
years except nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent
active infections No psychosis or mental disability that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior biological therapy
and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At
least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy
Endocrine therapy: At least 7 days since prior hormonal therapy and recovered
Radiotherapy: See Disease Characteristics Surgery: Not specified