Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

Inclusion Criteria

• •Histologically confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or metastatic. Surgery for primary or metastatic disease after chemotherapy following a response is allowed. Patients with the following tumor types are eligible:
• •* Undifferentiated pleomorphic sarcoma
• •* Leiomyosarcoma
• •* Malignant fibrous histiocytoma
• •* Liposarcoma (myxoid/round cell, pleomorphic or dedifferentiated)
• •* Synovial sarcoma
• •* Myxofibrosarcoma
• •* Angiosarcoma
• •* Fibrosarcoma
• •* Malignant peripheral nerve sheath tumor
• •* Epithelioid sarcoma
• •* Unclassified high-grade sarcoma (not otherwise specified)
• •* Soft tissue sarcoma for which treatment with an anthracycline is appropriate at the approval of the Principal Investigator (PI)
• •Measurable disease according to RECIST 1.1; that is, measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
• •Planning to initiate treatment with doxorubicin (starting dose 75 mg/m2) as routine care.
• •Prior adjuvant chemotherapy with gemcitabine and/or docetaxel/paclitaxel is allowed.
• •At least 18 years of age.
• •ECOG performance status of 0 or 1
• •Adequate organ function defined as:
• •* Leukocytes ≥ 3,000/mcL
• •* Absolute neutrophil count ≥ 1,500/mcl
• •* Platelets ≥ 100,000/mcl
• •* Total bilirubin ≤ 1.5 x IULN
• •* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
• •* Creatinine ≤ IULN OR Creatinine clearance ≥ 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal. Creatinine clearance should be calculated using the actual weight from day 1 of cycle
• •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• •Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).