title: Phase 1/11 study of bi-weekly irinotecan plus cisplatin in the treatment of advanced gastric cancer.
abstract: OBJECTIVE
  To conduct a phase I/II study of irinotecan with cisplatin to establish a recommended dose, and assess the safety, efficacy and feasibility of this regimen in unresectable advanced or recurrent gastric cancer.
  
  
  METHODS
  In the phase I portion of the study, patients received a fixed dose of cisplatin (30 mg/m2) with escalating doses of irinotecan, ranging from 30 mg/m2 to 70 mg/m2, on days 1 and 15. In the phase II portion of the study, 40 patients were evaluated for response and safety at the recommended dose.
  
  
  RESULTS
  Eighteen patients were enrolled in the phase I study. Dose-limiting toxicity (diarrhea and neutropenia) appeared at the irinotecan dose of 70 mg/m2. Therefore, the recommended irinotecan dose was 60 mg/m2. In the phase II study, 40 patients received cisplatin (30 mg/m2) plus irinotecan (60 mg/m2). Twenty-five out of 40 patients had received prior chemotherapy. The median number of cycles was 3.5. The response rate was 32.5% (13/40) overall, and 53.3% (8/15) in patients without prior chemotherapy. The median time to tumor progression (TTP) was 162 days. The median survival time was 288 days. Four patients (10%) developed grade 4 neutropenia and 3 patients (7.5%) developed grade 4 anemia. The only observed non-hematological toxicity at grade 3 or higher was diarrhea, seen in 2.5% (1/40) of the patients.
  
  
  CONCLUSIONS
  Bi-weekly administration of irinotecan and cisplatin is safe and active for the management of unresectable advanced or recurrent gastric cancer.
authors.affiliation: Department of Gastroenterology/Medical Oncology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
authors.forename: W
authors.initials: W
authors.lastname: Koizumi
authors.forename: M
authors.initials: M
authors.lastname: Kurihara
authors.forename: A
authors.initials: A
authors.lastname: Satoh
authors.forename: H
authors.initials: H
authors.lastname: Takiuchi
authors.forename: S
authors.initials: S
authors.lastname: Tanabe
authors.forename: K
authors.initials: K
authors.lastname: Shimada
authors.forename: R
authors.initials: R
authors.lastname: Iwasaki
authors.forename: K
authors.initials: K
authors.lastname: Saigenji
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin