Neoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site
Conditions
Brief summary
Arm1- bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion. Arm2- On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.
Interventions
DRUGBev + Gem + Doc
bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion.
DRUGGem + Doc
* Gemcitabine 1,000 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 30 minutes) * Docetaxel 35 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 60 minutes) On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy : neoadjuvnat or adjuvant chemotherapy is counted as one regimen 2. Age ≥19 years, \<80 years 3. ECOG performance status of 0-1 4. Has at least 1 measurable lesion (as defined by RECIST v1.1). 5. Has adequate organ function defined by the following criteria: * Hb ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1500 /µL * Platelet ≥ 75,000/ µL * Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis) * Serum Creatinine: ≥ 50 mL/min * AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis) * Alkaline Phosphatase (ALP): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis) 6. Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG 7. Able to provide written informed consent and comply with the protocol requirements
Exclusion criteria
1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study 2. More than 3 prior cytotoxic agents 3. previously received treatment with bevacizumab, gemcitabine, or docetaxel 4. Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria 5. Major surgery within 28 days prior to randomization. 6. Active or prior documented autoimmune or inflammatory disorders 7. Unstable cardiovascular disease 8. Has an active infection requiring parenteral treatment 9. History of another primary malignancy 10. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis 11. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study 12. Pre-existing interstitial lung disease (ILD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate, ORR | 2 year | Overall response rate (ORR) based on RECIST version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 2 year | The earlier of the date of first documented progressive disease or death from the date of enrollment |
| Overall survival (OS) | 2 year | From the date of treatment initiation to the date of death or last follow-up |
| Safety profile | 2 year | Safety profile assessed using CTCAE (version 5.0) |
Contacts
CONTACTHyo Song Kim, Professor
Outcome results
None listed