[Phase I clinical trial evaluation of capecitabine in concurrent combination of radiotherapy in nasopharyngeal carcinoma]

Ai Zheng. 2004 Apr;23(4):461-6.
[Article in Chinese]

Abstract

Background & objective: Capecitabine is an oral fluoropyrimidine, which is converted to fluorouracil (5-FU) by exploiting the comparatively higher activity of thymidine phosphorylase (TP) in tumor tissue. This study was designed to measure the maximum tolerated dose (MTD) of capecitabine in the patients with nasopharyngeal carcinoma.

Methods: Medical records of 36 patients with nasopharyngeal carcinoma treated with radiation and capecitabine were reviewed. The median dose of capecitabine was 1 600 mgx(m(2)xd)(-1) [700-2 500 mgx(m(2)xd)(-1)] orally for 2 weeks followed 1 week of rest and then another cycle. All the patients received a total dose ranging from 66 Gy to 74 Gy over 6-7.4 weeks.

Results: In the 2 300 mgx(m(2)xd)(-1) group, Grade III toxicities observed were hang-foot syndrome (1 patient) and diarrhea (1 patient).

Conclusion: Concurrent administration of capecitabine and radiation were tolerable in the patients with nasopharyngeal carcinoma. The maximum tolerated dose is 2 300 mgx(m(2)xd)(-1), The recommended phase II dose is 1 700 mgx(m(2)xd)(-1) daily administered by this intermittent schedule.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • English Abstract

MeSH terms

  • Adult
  • Aged
  • Capecitabine
  • Combined Modality Therapy
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use*
  • Female
  • Fluorouracil / analogs & derivatives
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Nasopharyngeal Neoplasms / therapy*
  • Radiotherapy Dosage

Substances

  • Deoxycytidine
  • Capecitabine
  • Fluorouracil