Application of a continual reassessment method to a phase I clinical trial of capecitabine in combination with cyclophosphamide and epirubicin (CEX) for inoperable or recurrent breast cancer

Jpn J Clin Oncol. 2004 Feb;34(2):104-6. doi: 10.1093/jjco/hyh016.

Abstract

A phase I clinical trial was started in order to determine the recommended doses of capecitabine and epirubicin, when administered in combination with a fixed dose of cyclophosphamide (600 mg/m(2) day 1 q3 weeks) in patients with inoperable or recurrent breast cancer. This study consists of five dose levels with combinations of three levels of epirubicin (75, 90 and 100 mg/m(2) day 1 q3 weeks) and three levels of capecitabine (1255, 1657 and 1800 mg/m(2)/day consecutive administration for 2 weeks followed by 1 week of rest). Dose escalation and de-escalation decisions are based on a continual reassessment method (CRM). We conducted a survey of the clinical oncologists participating in this trial to determine the dose escalation/de-escalation rule, including a prior distribution for model parameters used in the CRM.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Capecitabine
  • Cyclophosphamide / administration & dosage
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Epirubicin / administration & dosage
  • Female
  • Fluorouracil / analogs & derivatives
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*

Substances

  • Deoxycytidine
  • Epirubicin
  • Capecitabine
  • Cyclophosphamide
  • Fluorouracil