Advanced Gastric Cancer
Conditions
Interventions
Drug : CPT-11, and trastuzumab CPT-11 : 150 mg/m2 iv on day 1 Every two weeks Trastuzumab : 8 mg/kg iv on Day 1 (first course), and 6 mg/kg iv on Day 1 (from second courses) every 3 weeks
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction 2. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) 3.Patients who provided chemotherapy and confirmed progression by images 4. Patients who have measurable region defined by RECIST version 1.1 5. Age 20 years old or older 6. Performance status (ECOG scale) 0 or 2 7. Patients who can take food oraly 8. Adequate baseline organ and marrow function as defined below; a. Absolute neutrophil count : >=1,500/ mm3 b. Platelets : >=100,000/mm3 c. Hemoglobin: >=8.0 g/dL d. AST (SGOT)/ALT (SGPT) : < 150 IU/L e. Total bilirubin : <1.5 mg/dL f. Serum creatine : =<2.0 mg/dL 9. Life expectancy of greater than 3 months. 10.LVEF(Left Ventricular Ejection Fraction) is 50% or over 11. Patients should sign a written informed consent 12. Patient with/without prior chemotherapy of Trastuzumab, or Taxan(paclitaxel or docetaxel)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactDaisuke Sakai
Osaka University Graduate School of Medicine Department of Frontier Science for Cancer and Chemotherapy
Outcome results
None listed