Advanced Gastric Cancer
Conditions
Interventions
Drug: TS-1, cisplatin, and trastuzumab TS-1: 80 mg/m2/day po on Days 1-14 Cisplatin: 60 mg/m2 iv on Day 1 Trastuzumab: 8 mg/kg iv on Day 1 (first course), and 6 mg/kg iv on Day 1 (from second cours
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 no measurable legion defined by RECIST version 1.1 within 21 days before enrollment 3. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) 4. Age 20-75 5. Performance status (ECOG scale) 0 or 1 6. No prior chemotherapy or radiotherapy for gastric cancer 7. No massive ascites or massive pleural effusion retention 8. Patients without brain metastasis 9. Adequate baseline organ and marrow function as defined below; a) Leukocytes: >=3,500 /mm3 <=12,000 /mm3 b) Absolute neutrophil count: >=2,000 / mm3 c) Platelets: >=100,000 / mm3 d) Hemoglobin: >=9.0 g/dL e) AST (SGOT)/ALT (SGPT) < 100 IU/L f) Total bilirubin <1.5 mg/dL g) Serum creatine >=1.2 mg/dL h) Creatinine clearance: >=60 mL/min i) Patients with left ventricular ejection fraction of at least 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography done within 21 days before enrollment. 11. No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment 12. Patients able to take orally. 13. Life expectancy of greater than 3 months. 14. Patients should sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who are contraindicated to S-1, CDDP, and Trastuzumab 2. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant 3. Patient with active infection 4. Patients have Active hepatitis type B. 5. Serious illness or medical conditions as defined below, a) Patient with a previous history of congestive heart failure b) Hi-risk uncontrolled arrhythmias c) Unstable angina requiring medication d) Patient with a previous history of myocardial infarction e) Severe heart valve disease f) Patient with a previous history of transmural infarct g) Uncontrolled hypertension 6. Serious complication as followings, a) Interstitial pneumonia b) Pulmonary fibrosis c) Heart failure d) Renal failure e) Hepatic failure f) Uncontrolled diabetes mellitus 7. Patients with resting dyspnea 8. Patients with fresh bleeding from gastric cancer and/or the digestive tract 9. Patients with diarrhea (4 or more times per day or watery diarrhea). 10. Second primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence) 11. Patients who are received systemic continuous administration of flucytosine, phenytoin or warfarin 12. Patients who are received systemic administration of corticosteroid 13. Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Progression-free survival (PFS) Time to treatment failure (TTF) | — |
Countries
Japan
Contacts
Public ContactYukinori Kurokawa
Osaka University Graduate School of Medicine Department of Gastroenterological Surgery
Outcome results
None listed