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

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