title: The Safety of Pegylated Liposomal Doxorubicin Plus Irinotecan in Recurrent Ovarian Cancer Patients: A Phase I Trial.
abstract: OBJECTIVE
  The study was designed to evaluate the safety of combined chemotherapy with pegylated liposomal doxorubicin (PLD) and irinotecan (CPT-11) in patients with recurrent ovarian cancer.
  
  
  METHODS
  Six patients with platinum-resistant and taxane-pretreated ovarian cancer were enrolled in the study based on the traditional 3-plus-3 design. PLD was administered intravenously on day 1 and CPT-11 on days 1 and 8 of each 28-day course. Initial doses were 30 mg/m(2) PLD and 50 mg/m(2) CPT-11.
  
  
  RESULTS
  Hematotoxicity was the principal toxicity (1 patient developed grade 3 neutropenia and 2 developed grade 3 leukocytopenia); hand-foot syndrome was not observed. Furthermore, 1 patient achieved complete response, whereas 2 patients achieved partial response.
  
  
  CONCLUSIONS
  The combined PLD and CPT-11 regimen was well-tolerated indicating its potential clinical benefit for ovarian cancer patients.
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Miyahara
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
authors.forename: Taeko
authors.initials: T
authors.lastname: Ueda
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Katsuda
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Miyako
authors.initials: M
authors.lastname: Maehara
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fukagawa
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Miyata
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Sung Ouk
authors.initials: SO
authors.lastname: Nam
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Kondo
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan smiya@cis.fukuoka-u.ac.jp.
authors.forename: Shingo
authors.initials: S
authors.lastname: Miyamoto
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077216:Carcinoma, Ovarian Epithelial; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000077146:Irinotecan; D004317:Doxorubicin; D002166:Camptothecin
keywords: irinotecan; ovarian cancer; pegylated liposomal doxorubicin; phase I trial; safety