A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: Eribulin, gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated) ECOG performance status of 0-2 Measurable or evaluable disease (RECIST 1.1.) Adequate laboratory findings Hb ≥ 9.0 g/dL Absolute neutrophil count ≥ 1000 /µL Platelet ≥ 75,000/ µL Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis) Serum Creatinine: ≤1.5 X upper limit of normal (ULN) OR ≥ Creatinine Clearance 60 mL/min (Cockcroft-Gault) for patients with creatinine levels > 1.5 X institutional ULN AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis) Alkaline Phosphatase : ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis) Prothrombin time and partial thromboplastin time : ≤1.5 X ULN Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior Exclusion Criteria: More than 3 prior cytotoxic agents Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study Uncontrolled or active CNS metastasis and/or carcinomatous meningitis Patient has known hypersensitivity to the components of study drugs or its analogs. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. Long QT Syndrome ≥480 ms peripheral neuropathy ≥2 with previous treatment unstable cardiovascular disease Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eribulin+gemcitabine<br>The dose is 1.4 mg/m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg/m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle. | Drug: Eribulin, gemcitabine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | To evaluate antitumor efficacy of eribulin and gemcitabine combination | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event | to evaluate safety | through study completion, an average of 6 months |