HER2-negative, Claudin-positive unresectable advanced or recurrent gastric cancer
Conditions
Interventions
Initiate the first administration of Zolbetuximab at 100 mg/m2/h and increase the infusion rate to 200 mg/m2/h, 300 mg/m2/h, and 400 mg/m2/h
Sponsors
Gifu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with HER2-negative, Claudin-positive unresectable advanced or recurrent gastric cancer who are scheduled to receive Zolbetuximab-containing cancer chemotherapy for the first time - Patients with no history of chemotherapy with moderate emetic risk and high emetic risk anticancer drugs - Patients scheduled to receive antiemetic therapy that includes at least three drugs: 5-HT3RA, NK1RA, and dexamethasone as prophylactic antiemetic therapy - Patients who can accurately maintain a patient diary - Patients aged 20 years or older on the registration date - Latest laboratory values within 2 weeks before registration meeting all of the following criteria: - Total bilirubin (T-bil) <= 2.0 mg/dL - Aspartate aminotransferase (AST) <= 100 U/L - Alanine aminotransferase (ALT) <= 100 U/L - Creatinine clearance (CCr) >= 45 mL/min
Exclusion criteria
Exclusion criteria: - Patients who start Zolbetuximab at a reduced dose - Patients with nausea (Grade 2) requiring antiemetic treatment at the time of registration - Patients with vomiting at the time of registration - Patients who started narcotic medications (strong opioids) within 48 hours before registration - Patients with ascites requiring therapeutic paracentesis - Patients with symptomatic brain metastasis and carcinomatous meningitis - Patients with gastrointestinal disorders such as bowel obstruction - Patients who have received radiation therapy to the abdomen (below the diaphragm) or pelvis within 6 days before registration; however, patients who have received localized radiation therapy to bone parts for bone metastases (e.g., lumbar spine) are not excluded - Patients taking certain medications within 48 hours before starting treatment - Patients otherwise deemed inappropriate for participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The infusion rate at which Grade 2 or higher nausea/vomiting (requiring infusion interruption or rate adjustment) first occurs during the first cycle. | — |
Countries
Japan
Contacts
Public ContactHirotoshi Iihara
Gifu University Hospital Department of Pharmacy
Outcome results
None listed