title: A phase I/II study of carboplatin and paclitaxel in patients with epithelial ovarian cancer.
abstract: BACKGROUND
  This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin-paclitaxel combination chemotherapy in patients with epithelial ovarian cancer.
  
  
  METHODS
  One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m(2). The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated.
  
  
  RESULTS
  After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m(2) administration group, we chose 175 mg/m(2) as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19-907 days) and 66.7%, respectively.
  
  
  CONCLUSIONS
  Combination chemotherapy using paclitaxel 175 mg/m(2) and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.
authors.affiliation: Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan. rityam@med.hokudai.ac.jp
authors.forename: Ritsu
authors.initials: R
authors.lastname: Yamamoto
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Minobe
authors.forename: Masanori
authors.initials: M
authors.lastname: Kaneuchi
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sakuragi
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Fujimoto
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ishizaki
authors.forename: Hiroka
authors.initials: H
authors.lastname: Domon
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Hareyama
authors.forename: Chikara
authors.initials: C
authors.lastname: Sato
authors.forename: Takahumi
authors.initials: T
authors.lastname: Fujino
authors.forename: Isao
authors.initials: I
authors.lastname: Kawaguchi
authors.forename: Tatsumi
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Toshio
authors.initials: T
authors.lastname: Fujimoto
authors.forename: Ken
authors.initials: K
authors.lastname: Yoshiaki
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002277:Carcinoma / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D016190:Carboplatin; D017239:Paclitaxel