Sarcoma
Conditions
Brief summary
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.
Interventions
DRUGEribulin, gemcitabine
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
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated) 2. ECOG performance status of 0-2 3. Measurable or evaluable disease (RECIST 1.1.) 4. 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 5. Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior
Exclusion criteria
1. More than 3 prior cytotoxic agents 2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study 3. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis 4. Patient has known hypersensitivity to the components of study drugs or its analogs. 5. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. 6. Long QT Syndrome ≥480 ms 7. peripheral neuropathy ≥2 with previous treatment 8. unstable cardiovascular disease 9. Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 12 weeks | To evaluate antitumor efficacy of eribulin and gemcitabine combination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse event | through study completion, an average of 6 months | to evaluate safety |
Countries
South Korea
Outcome results
None listed