- Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with
- Target tumors outside prior radiation field(s).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil
- Adequate renal function
- Adequate liver function
- No history of hemorrhagic cystitis or evidence of microscopic hematuria
- Capable of understanding the protocol requirements and risks and providing written
- Either 0 or 1 prior chemotherapy regimens
- Subject has a diagnosis of gastrointestinal stromal tumors.
- Concurrent serious medical illness unrelated to tumor within the past 6 months.
- Known chronic infectious disease, such as AIDS or hepatitis.
- Positive screening pregnancy test or is breast-feeding.
- A female or male subject of reproductive capacity unwilling to use methods
appropriate to prevent pregnancy during the course of this study.
- Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide
field radiation within the previous 4 weeks.
- History of another active malignancy (except non-melanoma skin cancer and carcinoma
in situ of the cervix), unless in complete remission and off all therapy for that
disease for the last 2 years.
- Known or clinically suspected brain metastases.
- Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant
therapy) for soft tissue sarcoma.
- Received any investigational drug within the last 30 days.
- Not fully recovered from any prior surgery (at least 4 weeks recovery period for
major surgery), and from any reversible side effects related to the administration of
cytotoxic chemotherapy or radiation therapy.
- Received a prior camptothecin analog (e.g., topotecan, irinotecan).