Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorYonsei University
About this trial
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.
Eligibility criteria
Qualifiers
Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy
Age ≥19 years, <80 years
ECOG performance status of 0-1
Has at least 1 measurable lesion (as defined by RECIST v1.1).
Disqualifiers
Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
More than 3 prior cytotoxic agents
previously received treatment with bevacizumab, gemcitabine, or docetaxel
Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria
Trial design
Treatments tested in this trial
- Bev + Gem + Doc
- Gem + Doc
Treatment groups
92 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov