[A phase I study of combination therapy with capecitabine and paclitaxel for patients with inoperable breast cancer or recurrent breast cancer]

Gan To Kagaku Ryoho. 2008 Nov;35(11):1877-81.
[Article in Japanese]

Abstract

A dose-escalation study was conducted for patients with inoperable or recurrent breast cancer in order to determine the recommended dose (RD) of capecitabine combined with a fixed dose of weekly paclitaxel. Capecitabine was administered twice daily from day 1 through day 14 combined with paclitaxel given on days 1 and 8, every 21 days. Dose-limiting toxicities(DLT)were evaluated during the first two cycles. Three patients were recruited at one of two dose levels (capecitabine 1,255 mg/m2 or 1,657 mg/m2, paclitaxel 80 mg/m2). In this study, no DLT was seen in each level, and the RD of capecitabine was determined to be 1,657 mg/m2.

Publication types

  • Clinical Trial, Phase I
  • English Abstract

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Capecitabine
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Dose-Response Relationship, Drug
  • Female
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives*
  • Fluorouracil / therapeutic use
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Paclitaxel / adverse effects
  • Paclitaxel / therapeutic use*

Substances

  • Deoxycytidine
  • Capecitabine
  • Paclitaxel
  • Fluorouracil