Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy
- Conditions
- Advanced Gastric Cancer
- Registration Number
- JPRN-UMIN000008626
- Lead Sponsor
- Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. with active double cancer 2. with prior chemotherapy of CPT-11 3. with local/general active infectious disease 4. Serious complication as followings, a.bleeding on digestive tract b.Ileus c.intestinal paralysis d. Interstitial pneumonia e. Pulmonary fibrosis f. ischemic heart disease or cardiac dysrhythmia requiring treatment g. Heart failure h. Renal failure i. Hepatic cirrhosis j. glaucoma k. Uncontrolled diabetes mellitus 5. with uncontrollable diarrhea 6. with a history of severe allergy 7. with a middle or large volume of ascites and/or pleural fluid 8. with a continuous administration of steroids 9. with a difficulty on registration to This study due to psychological disease 10. with a central nerve metastasis 11. With administration of atazanabil 12. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant. 13. Patients have Active hepatitis type B and/or hepatitis C. 14. Any patients judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Control Rate
- Secondary Outcome Measures
Name Time Method Incidence and grade of AE Progression-free survival (PFS) Overall survival (OS) Response Rate (RR) Time to treatment failure (TTF) RR stratified by prior chemotherapy