Clinical trial NCT03810976: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: progression free survival
timeFrame: 12 weeks
Secondary outcomes:
measure: adverse event
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References: