title: A combination phase I study of weekly paclitaxel and doxifluridine in advanced gastric cancer patients.
abstract: BACKGROUND
  Preclinical studies have shown that paclitaxel and doxifluridine can act synergistically without overlapping toxicity for the treatment of advanced gastric cancer. The objectives of this study were to determine the maximum tolerated dose (MTD), the dose-limiting toxicity and the recommended Phase II dose for this drug combination.
  
  
  METHODS
  Patients with histologically confirmed gastric cancer were eligible for the study. The paclitaxel dose (days 1, 8, 15) was augmented with a fixed dose of for treatments (1-3). doxifluridine (533 mg/m2, 5 days/week) on a 28-day cycle.
  
  
  RESULTS
  Eighteen patients were enrolled. The MTD was not reached until the highest dose level. One patient had Grade 3 myelosuppression. The responses of the 13 suitable patients included 1 complete response and 5 partial responses.
  
  
  CONCLUSIONS
  Although the MTD level could not be definitively which is a established, upon consideration of the lengthy administration time and the effectiveness, the recommended Phase II dose of paclitaxel was concluded to be 80 mg/m2 in combination with doxifluridine at 533 mg/m2.
authors.affiliation: Second Department of Surgery, Gunma University, Faculty of Medicine, Japan. takeyosi@showa.gunma-u.ac.jp
authors.forename: Izumi
authors.initials: I
authors.lastname: Takeyoshi
authors.forename: Fujio
authors.initials: F
authors.lastname: Makita
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Tanahashi
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Yokomori
authors.forename: Shigeru
authors.initials: S
authors.lastname: Iwazaki
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kawashima
authors.forename: Kotaro
authors.initials: K
authors.lastname: Iwanami
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Yamada
authors.forename: Susumu
authors.initials: S
authors.lastname: Kawate
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Hamada
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Sunose
authors.forename: Miho
authors.initials: M
authors.lastname: Yoshida
authors.forename: Jun
authors.initials: J
authors.lastname: Horiguchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Iesato
authors.forename: Mitsunobu
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Morishita
mesh_terms: D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005467:Floxuridine / Q000008:administration & dosage* / Q000009:adverse effects; D006410:Hematopoiesis / Q000187:drug effects; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D005467:Floxuridine; D017239:Paclitaxel; C025034:doxifluridine