A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpressio
- Conditions
- nresectable advanced or recurrent gastric cancer with HER2 overexpression
- Registration Number
- JPRN-UMIN000008292
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. HER2 IHC- or IHC1+, or IHC2+/FISH- 2. Ejection fraction on echo cardiogram<=50% 3. Discontinuation of trastuzumab in first-line chemotherapy due to adverse reaction of trastuzumab 4. Intestinal paralysis or ileus 5. Uncontrolled diarrhea 6. Massive ascites or pleural effusion 7. Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 8. Uncontrolled diabetes 9. Uncontrolled hypertension 10. Unstable angina pectoris, or a history of myocardial infarction within six months 11. Synchronous cancers 12. Systemic infection requiring treatment 13. Fever above 38 degree Celsius 14. A possibility of pregnancy or during pregnancy, or lactating women 15. Psychosis or psychotic symptoms 16. Continuous systemic administration of steroids (oral or intravenous) 17. Hypersensitivity to ingredients of irinotecan or trastuzumab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method