Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer

Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 35 人开始时间: 2011年9月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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

发起方

Japanese Foundation for Multidisciplinary Treatment of Cancer