This phase II trial studies how well doxorubicin hydrochloride and dexrazoxane hydrochloride work in treating patients with soft tissue sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment and cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect normal cells from the side effects of chemotherapy. Giving doxorubicin hydrochloride and dexrazoxane hydrochloride may work better in treating patients with soft tissue sarcoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02584309.
PRIMARY OBJECTIVE:
I. To determine progression-free survival (PFS) in patients with metastatic soft tissue sarcoma who are treated with doxorubicin (doxorubicin hydrochloride) in combination with dexrazoxane (dexrazoxane hydrochloride).
SECONDARY OBJECTIVES:
I. To determine cardiac-related mortality in patients with metastatic soft tissue sarcoma who are treated with doxorubicin in combination with dexrazoxane.
II. To determine incidence of heart failure or cardiomyopathy in patients with metastatic soft tissue sarcoma who are treated with doxorubicin in combination with dexrazoxane.
III. To evaluate additional echocardiogram parameters of left ventricular ejection fraction to determine if either 3-dimensional (3D) echocardiogram or ventricular strain is able to serve as an early marker of cardiac dysfunction compared to 2-dimensional (2D) echocardiogram modified Simpson’s biplane method of left ventricular ejection fraction (LVEF).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1: Patients receive dexrazoxane hydrochloride intravenously (IV) over 15 minutes and doxorubicin hydrochloride IV on day 1.
COHORT 2: Patients receive doxorubicin hydrochloride IV on day 1.
In both cohorts, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients in cohort 1 are followed up every 3 months for up to 5 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorBrian Andrew Van Tine