title: A phase II trial of trastuzumab combined with irinotecan in patients with advanced HER2-positive chemo-refractory gastric cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group OGSG1203 (HERBIS-5).
abstract: Irinotecan is a key drug in second- or further-line chemotherapy for patients with advanced gastric cancer. Continuous administration of trastuzumab beyond first progression is expected to contribute to the benefit of chemotherapy for human epidermal growth factor receptor 2-positive gastric cancer. The aim of this trial is to evaluate the efficacy and safety of combination chemotherapy with trastuzumab and irinotecan in Japanese patients with advanced human epidermal growth factor receptor 2-positive chemo-refractory gastric cancer. The primary endpoint is the disease control rate. The secondary endpoints are adverse events, overall response rate, time to treatment failure, progression-free survival, overall survival and response rate stratified by prior trastuzumab use. A total of 30 patients will be enrolled in this Osaka Gastrointestinal Cancer Chemotherapy Study Group trial.
authors.affiliation: Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Sakai
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kudo
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Oka
authors.forename: Toshimasa
authors.initials: T
authors.lastname: Tsujinaka
authors.forename: Toshio
authors.initials: T
authors.lastname: Shimokawa
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D013274:Stomach Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000972:Antineoplastic Agents, Phytogenic; D014408:Biomarkers, Tumor; D002166:Camptothecin; D000077146:Irinotecan; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: chemo-GI tract HER2-positive; irinotecan; trastuzumab