title: Phase I study of combination chemotherapy consisting of paclitaxel, cisplatin, and S-1 in patients with unresectable gastric cancer (KOGC-02).
abstract: BACKGROUND
  Triplet combination chemotherapy has the potential to improve the prognosis of patients with unresectable gastric cancer. We conducted a phase I trial of triplet combination chemotherapy consisting of paclitaxel, cisplatin, and S-1 (PCS) for unresectable gastric cancer.
  
  
  METHODS
  Patients with metastatic or incurable disease were enrolled. S-1 was administered on days 1-14. Paclitaxel and cisplatin were infused on days 1 and 15. The starting doses of paclitaxel and cisplatin were 100 and 20 mg/m(2), respectively. Dose levels of paclitaxel and cisplatin were escalated as follows: 120 and 20 mg/m(2), respectively (level 2); 120 and 30 mg/m(2), respectively (level 3). End-points: Dose-limiting toxicities included grade 3 nausea, vomiting, and general fatigue, and grade 4 febrile neutropenia. The maximum tolerated dose and recommended dose were established at level 3 and level 2, respectively.
  
  
  CONCLUSIONS
  Although further clinical trials are recommended to more thoroughly evaluate safety and efficacy, PCS appears to be an excellent candidate for a standard treatment strategy for unresectable gastric cancer.
authors.affiliation: Department of Surgery, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan.
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Takahashi
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Saikawa
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fukuda
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Funakoshi
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kawakubo
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takeuchi
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Takaishi
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D002945:Cisplatin