HER2-positive gastric cancer
Conditions
Interventions
Trastuzumab: 8mg/kg(i.v.) for the initial dosing and 6mg/kg for subsequent administration at day 1 nab-Paclitaxel: 180-260mg/m2 administration at day 1 (dose escalation: level 0 - 180mg/m2,level 1 =
Sponsors
Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology
Kyoto City Hospital, Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological confirmed unresectable advanced or recurrent gastric cancer 2. Positive HER2 status (IHC3+ or IHC2+/FISH+) 3. Age over 20 years old 4. Cases with measurable lesion 5. No previous chemotherapy or radiation therapy for malignant tumor except for gastric cancer 6. Refractory to fluoropyrimidine, platinum and trastuzumab containing chemotherapy 7. Prior trastuzumab therapy with more than three doses, and within 6 weeks from last trastuzumab administration 8. No prior therapy with taxan 9. No prior therapy with anti-HER2 drugs except trastuzumab 10. No clinical ileus or subileus 11. ECOG performance status 0-2 12.Cases expected to survive for 90 days or more 13. Cases with adequately maintained organ functions and fullfilling the following conditions within 2 weeks before registration. leukocyte count <= 12000/mm3 neutrophil count >= 1,500/ mm3 hemoglobin level >= 8.0g/ dL platelet count >= 75,000/mm3 AST and ALT <= 100IU/L, or AST and ALT <= 200IU/L with liver metastases total bilirbin <= 1.5mg/dL serum creatinine <= 1.5mg/dL 14. Left ventricular ejection fraction (LVEF) >= 50% measured by echocardiography or multi-gated acquisition scan (MUGA) 15. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Discontinuation of tratuzumab due to adverse event 2. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma 3. Evidence of any other serious disease 4. Active local or systemic infection under treatment 5. History of serious allergic reaction 6. Pulmonary fibrosis or interstitial pneumonitis detected by chest X-ray 7. Symptomatic brain metastases or carcinomatous meningitis 8. Massive pericardial effusion, pleural effusion or ascites 9. Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0 10. Pregnant or lactating female 11. Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Maximum tolerated dose and recommended dose Phase 2: Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: Response rate(RR), incidence and degree of adverse events Phase 2: Progression free survival (PFS), Overall survival (OS), Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactTakeshi Ishikawa
Kyoto Prefectural University of Medicine Gatroenterology and Hepatology
Outcome results
None listed