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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810976
• Other study ID #: 4-2017-0933
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2018
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyosarcoma
• Liposarcoma
• Sarcoma

Intervention

Drug:
• Eribulin, 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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	To evaluate antitumor efficacy of eribulin and gemcitabine combination	12 weeks
Secondary	adverse event	to evaluate safety	through study completion, an average of 6 months