HER2-positive advanced gastric cancer
Conditions
Interventions
Drug:TS-1 and Trastuzumab TS-1:80mg/m2/dat on Day 1-28 Trastuzumab:6mg/kg/body on Day 1 and Day 22 (first time: 8mg/kg/body)
Sponsors
Japna Clinical Cancer Research Organizetion
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 measurable region defined by RECIST version 1.1. 3) Patients who have HER2-positive cancer confirmed with IHC and /or FISH (IHC 3+ or IHC2+ and FISH positive) 4) More than 65 years old. 5) Performance status (ECOG scale) 0, 1 or 2. 6) No prior chemotherapy or radiotherapy for gastric cancer. 7) Adequate baseline organ and marrow function as defined below: 1. Leukocyte : 3,500-12,000/mm3 2. Absolute neutrophil count : >= 2,000/mm3 3. Platelets : >= 100,000/mm3 4. Hemoglobin : >=9.0g/dL 5. AST : < 100IU/L 6. ALT : < 100IU/L 7. Total bilirubin : < 1.5mg/dL 8. Serum creatinine : <= 1.2mg/dL 9. Creatinine clearance : >= 50ml/min 8) Patients with left ventricular ejection fraction of at leaset 50% on MUGA scan or echocardiography done within 21days before enrollment. 9) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment 10) Patients able to take orally 11)Life expectancy of greater than 3 months 12) Patients should sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Scond primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence) 2) Severe ascites and / or pleural effusion 3) Patients with brain metastasis 4) Patients with fresh bleeding from gastric cancer and / or the digestive tract 5) Patients with active infection (> 38C) 6) Patients have active hepatitis type B 7) Patients with a previous history of congestive heart failure 8) Unstable angina requiring medication 9) Patients with a previous history of transmural infarct 10) Uncontrolled hypertension 11) Severe heart valve diseases 12) Hi-risk uncontrolled arrhythmias 13) Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus 14) Patients with resting dyspnea 15) Patients with diarrhea (4 or more times per day or watery diarrhea) 16) Patients who are contraindicated to TS-1 and Trastuzumab 17) Hypersensitivity to have a history TS-1 and / or Trastuzumab 18) Patients who are received systemic continuous admnistration of flucytosine. 19) Patients who are recieving systemic continuous administration of phenytoin or warfarin 20) Patients who are received systemic administration of corticosteroid for a long time or with high doses 21) Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. Men who want their partners to become pregnant. 22) Any patinets judged by the investigator to be unfit to perticipate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS) Progression free survaval(PFS) Time to treatment faulure(TTF) Safety | — |
Countries
Japan
Contacts
Public ContactMasashi Fujii
Japan Clinical Cancer Research Organization Secretariat
Outcome results
None listed