Trial Information

Summary: A phase II study of escalating doses of infusional single agent epirubicin hydrochloride (Ellence™) for treatment of advanced soft tissue sarcoma, with correlative studies of cardiac toxicity, tissue analysis for multidrug resistance (MDR), and evaluation of MDR by technetium-99m MIBI SPECT

Study Description

The primary objective of this study is to evaluate the rate at which patients with advanced soft tissue sarcoma respond to escalating doses of Epirubicin hydrochloride given as a continuous, 48-hour infusion every 21 days for 6 cycles or until the disease worsens. Doses of chemotherapy will be increased each cycle, beginning at 90 mg/m², reaching the highest dose of 140 mg/m² at cycle 6. After patients are removed from study participation they will be followed for survival.

Patient Inclusion/Exclusion Criteria

Up to 30 adult patients with histologically confirmed soft tissue sarcoma, which is either primary unresectable, locally advanced or metastatic will be enrolled to this study. Up to 2 prior chemotherapy regimens are allowed (excluding anthracyclines chemotherapy) as well as prior radiation therapy. Referral from the consultation service may take place only with the agreement of the responsible attending physician.

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