Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

Inclusion Criteria: Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease. 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 count. 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 informed consent. Either 0 or 1 prior chemotherapy regimens Exclusion Criteria: 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).