Back to resultsA Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eribulin, gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma
Eligibility Criteria
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
Sites / Locations
- Severance Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eribulin+gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
progression free survival
To evaluate antitumor efficacy of eribulin and gemcitabine combination
Secondary Outcome Measures
adverse event
to evaluate safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03810976
Brief Title
A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma
Official Title
Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eribulin+gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Eribulin, gemcitabine
Intervention Description
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
Primary Outcome Measure Information:
Title
progression free survival
Description
To evaluate antitumor efficacy of eribulin and gemcitabine combination
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
adverse event
Description
to evaluate safety
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma
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