Randomized phase II study comparing trastuzumab plus weekly paclitaxel with weekly paclitaxel alone for patients with HER2-positive advanced gastric or gastro-esophageal junction cancer refractory to trastuzumab combined with fluoropyrimidine and platinum. - Trial to Assess the Concept of using Trastuzumab beyond progression

West Japan Oncology Group0 个研究点目标入组 90 人开始时间: 2012年11月9日最近更新: 2023年10月17日

研究概览

暂无简介。

•1) Discontinuation of trastuzumab due to adverse event. 2) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 3) Evidence of any other serious disease, e.g. active gastrointestinal hemorrhage, uncontrolled cardiovascular disease and uncontrolled diabetes mellitus. 4) Active infection under treatment. 5) History of serious allergic reactions. 6) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray. 7) Symptomatic brain metastases or carcinomatous meningitis. 8) Massive pericardial effusion, pleural effusion or ascites*. *except for patients if effusions and ascites did no accumulate for more than two weeks after dranage therapy. *include patients if pleurosclerosis was performed with anti-cancer drugs except OK-432. 9) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0. 10) Current treatment with corticosteroids. 11) Blood tests positive for HBs antigen. 12) Active gastrointestinal hemorrhage requiring multiple blood transfusions. 13) Uncontrolled psychiatry disease. 14) Pregnant or lactating female. 15) Judged inappropriate by the investigators.

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