title: A phase I study of capecitabine combined with CPT-11 in metastatic breast cancer pretreated with anthracyclines and taxanes.
abstract: OBJECTIVE
  A dose escalation study of biweekly irinotecan (CPT-11) combined with capecitabine was performed to determine the maximum tolerated dose (MTD) and recommended dose (RD) for metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes.
  
  
  METHODS
  Escalating doses of CPT-11 (80-120 mg/m(2)) were administered on days 1 and 15. Capecitabine was administered at a fixed dose of 1,657 mg/m(2)/day for 21 consecutive days, followed by 7 days of rest. We treated 3-6 patients at a particular dose level until the MTD was determined.
  
  
  RESULTS
  Twenty patients were treated. The MTD was determined to be 100 mg/m(2), as 3 of 6 patients developed dose-limiting toxicities, grade 3 leukopenia, neutropenia, photophobia, fatigue and diarrhea. The RD for the phase II study was thus determined to be 90 mg/m(2). The response rate was 41.7%.
  
  
  CONCLUSIONS
  Combination therapy with CPT-11 and capecitabine was well tolerated with a promising response rate for MBC that had been treated previously with anthracyclines and taxanes. A multi-center phase II study is warranted to evaluate the efficacy and safety of this combination therapy with pharmacokinetic assessment.
authors.affiliation: Department of Surgery, Iwate Medical University, Morioka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kashiwaba
authors.forename: Toru
authors.initials: T
authors.lastname: Inaba
authors.forename: Hideaki
authors.initials: H
authors.lastname: Komatsu
authors.forename: Kazushige
authors.initials: K
authors.lastname: Ishida
authors.forename: Ryoko
authors.initials: R
authors.lastname: Kawagishi
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Matsui
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Uesugi
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Sugai
authors.forename: Go
authors.initials: G
authors.lastname: Wakabayashi
mesh_terms: D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D018943:Anthracyclines; D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin