A Phase 1/2 interventional study of trastuzumab, bevacizumab with paclitaxel (triple combination) in HER2-positive Advanced Gastric Cancer, sponsored by Kangbuk Samsung Hospital. Recruiting at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Kangbuk Samsung Hospital · Phase 1/2, Interventional, and Treatment
This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.
Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.
HER2-positive advanced gastric cancer
as patients with adequate organ function
Exclusion Criteria:
Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years
This is a single arm study. Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.
Drug: trastuzumab, bevacizumab with paclitaxel (triple combination)
Trastuzumab 4 mg/kg Day 1, 15 Bevacizumab 5 mg/kg Day 1, 15 Paclitaxel 80 mg/m2 Day 1, 8, 15 every 4 weeks
Progression-free survival
Defined as the time from the start of treatment to the date of documented disease progression (according to RECIST 1.1) or death from any cause.
Time frame: up to 36 months
Plan to share: No
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Kangbuk Samsung Hospital