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

Study start date: August 1, 2003

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).