title: Phase I study of docetaxel, cisplatin and concurrent radiotherapy for locally advanced gastric adenocarcinoma.
abstract: This phase I study is designed to determine the maximal tolerated dose and the dose-limiting toxicity of docetaxel with cisplatin and concurrent radiotherapy in patients with unresectable locally advanced gastric adenocarcinoma. Docetaxel was given once a week with the dosage escalated from 5 mg/m(2) to 15 mg/m(2) in increments of 2.5 mg/m(2). Cisplatin were administered at 20 mg/m(2) once a week. Radiotherapy was delivered to 50.4Gy at 1.8Gy/day. At least three patients were enrolled at each level. The maximal tolerated dose (MTD) and dose-limiting toxicity (DLTs) was determined. The DLTs were defined as grade 3 or 4 hematologic and nonhematologic toxicity. Twenty-one patients with locally advanced gastric adenocarcinoma were enrolled. Grade 1-2 neutropenia and nausea/vomiting were the most common side effects. The first DLT (grade-3 neutropenia) was observed in one of three patients at 12.5 mg/m(2) docetaxel. Three more patients were enrolled, but DLT was not observed and 6 patients were enrolled into 15 mg/m(2) group, DLT occurred in 3 patients (1 Grade 3 neutropenia, 1 Grade 4 neutropenia and 1 Grade 3 nausea/vomiting). Overall tumor response rate was 66.7% with 28.6% complete and 38.1% partial response. In conclusion, the MTD of docetaxel was 15 mg/m(2), and the recommended dose of docetaxel for Phase II study was 12.5 mg/m(2) weekly. The docetaxel and cisplatin with concurrent radiotherapy were tolerable and feasible in treating locally advanced gastric adenocarcinoma.
authors.affiliation: Department of Radiation Oncology and Shandong Province Key Laboratory of Radiation Oncology, Shandong Cancer Hospital, Shandong Academy of Medical Sciences, China.
authors.forename: L
authors.initials: L
authors.lastname: Xing
authors.forename: H
authors.initials: H
authors.lastname: Lu
authors.forename: J
authors.initials: J
authors.lastname: Zhang
authors.forename: J
authors.initials: J
authors.lastname: Yu
authors.forename: F
authors.initials: F
authors.lastname: Wang
authors.forename: X
authors.initials: X
authors.lastname: Yu
authors.forename: H
authors.initials: H
authors.lastname: Yu
authors.forename: L
authors.initials: L
authors.lastname: Xia
mesh_terms: D000230:Adenocarcinoma / Q000556:secondary / Q000628:therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D013274:Stomach Neoplasms / Q000473:pathology / Q000628:therapy*; D043823:Taxoids / Q000008:administration & dosage; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin