HER2 positive advanced or recurrent gastric cancer
Conditions
Interventions
Trastuzumab : 8 mg/kg(i.v.) for the initial dosing and 6 mg/kg for subsequent administration.
Trastuzumab administration will be repeated every 3 weeks.
Paclitaxel : 80 mg/m2 administered weekly on
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histlogically confirmed Gastric adenocarcinoma 2) Age: 20 years or older 3) HER2 positive (IHC 3+ or IHC 2+ /FISH +) 4)Previous chemotherapy completed at least 14 days before. 5) received one or more prior chemotherapy for gastric carcinoma, does not include trastuzumab and taxanes. 6)History of chemotherapy must be contain 5-fluoropyrimidine 7) Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline. 8)Performance Status (ECOG scale) 0-2 9)Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of >= 50% required) 10) Adequate organ function as follows: i) neutrophils >=1,500/mm3, ii) platelets >=100,000/mm3, iii) hemoglobin >=8.0g/dL, iv) total bilirubin <=1.5mg/dL, v) AST(GOT)/ALT(GPT) <=100IU/L, in hepatic metastasis <=200IU/L, vi) serum creatinine <2.0mg/dL or creatinine clearance >=30mL/min. 11)Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Active synchronous or metachronous malignancy carcinoma in situ. 2) Severe or uncontrolled medical conditions (e.g.; infection, pulmonary fibrosis, intestinal paralysis, ileus, uncontrolled diabetes mellitus, cirrhosis, myocardial infarction and unstable angina.) 3) Severe infection and inflammation. 4) Severe mental disorders. 5) Peripheral motor or sensory neuropathy of CTCAEver.4.0 Grade2 or more. 6) Cardiac effusion, pleural or peritoneal effusion requiring treatment. 7) Polyoxyethylene Castor Oil allergy. 8) Administration of disulfiram,cyanamide,carmofur and procarbazine hydrochloride. 9)Pregnant or lactating female at anytime during the study 10) Other patients who are not suitable t for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Overall Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival Time to Treatment Failure Overall Survival Adverse events | — |
Countries
Japan
Outcome results
None listed