Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

To be eligible, each patient must meet EACH of the following criteria: * Age ≥18 years. * Documented soft tissue sarcoma * Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable. * ECOG Performance Status of 0, 1 or 2 * Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests * Male and female patients must agree to use a highly reliable method of birth control during study participation. * Able to provide informed consent To be eligible, each patient must meet NONE of the following criteria: * Specific sarcoma histological subtypes including GIST and Ewing's sarcoma. * Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease * Any prior anthracycline use. * Known allergy to any of the study drugs or their excipients. * Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol). * Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) \