HER2-positive metastatic or advanced gastric cancer
Conditions
Interventions
trastuzumab wiht irinotecan started within 2 weeks of enrollment and repeated until disease progression, unacceptable toxicity, or withdrawal of consent 1. trastzumab given by intravenous infusion in
Sponsors
NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histologically, confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach 2. HER2 status scored as 3+ on immunohistochemistry or fluorescence in-situ hybridization positive 3. prior trastuzumab and resistant radiologically confirmed disease progression within 28 days after last dose of 1st line therapy including trastuzumab 4. CT or MRI imaging of disease progression of 1st line therapy by RECIST criteria ver. 1.1 within 28 days of enrollment, and mesurable lesions 5. 14 days or more after last dose of 1st line therapy 6. no prior irinotecan 7. aged 20 or older 8. ECOG performance status 0-2 9. adequate organ function within 14 days of enrollment 10. adequate cardiac function: LVEF 50% or more by echocardiography or MUGA scan within 3 months of enrollment 11. written first-person informed consent
Exclusion criteria
Exclusion criteria: 1. past or current history(within the last 5 years) of malignancies except for the indication under this study and curatively treated: -Basal and squamous cell carcinoma of the skin -In-situ carcinoma of the cervix 2. serious and/or uncontrolled complications(infection, pulmonary fibrosis, bowel paralysis, bowel obstrucion, uncontrolled diabetes, hepatic cirrhosis, uncontrolled hypertension, current history(within a year) of myocardial infarction and/or unstable angina) 3. active(obvious or uncontrolled) gastrointestinal hemorrhage 4. cardiac effusion, pleural and/or peritoneal effusion requiring treatment of drainage 5. pregnancy and lactation, and/or without intention of virth control 6. any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, six-month survival rate, safety, sub-group analysis by HER2 status(IHC3+, IHC2+/FISH+), sub-group analysis by retesting of HER2 status(retest, no retest), sub-group analysis by HER2 status in HER2 resteted population(changed from most positive and/or positive to positve and/or negative, not changed) | — |
Countries
Japan
Contacts
Public ContactNanako Ono
Hokkaido University Hospital Department of Clinical Trial Management
Outcome results
None listed