The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1\& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1\& Day 8 every 3 weeks
Severance Hospital, Yonsei University Health System
Seoul, South Korea
progression free survival
To evaluate antitumor efficacy of eribulin and gemcitabine combination
Time frame: 12 weeks
adverse event
to evaluate safety
Time frame: through study completion, an average of 6 months
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