A phase I trial of docetaxel based induction and concomitant chemotherapy in patients with locally advanced head and neck cancer

Cancer Invest. 2007 Sep;25(6):435-44. doi: 10.1080/07357900701357993.

Abstract

The purpose of this study was to determine the maximum tolerated dose (MTD) of docetaxel based induction and concomitant chemoradiotherapy (CRT) after using the FHX platform (5 = 5-FU, H = hydroxyurea, X = Radiation). Patients with Stage III/IV locally advanced HNSCC were enrolled. Induction chemotherapy (carboplatin/docetaxel) was followed by 5 cycles of concomitant docetaxel based CRT. No DLTs were observed in dose levels 1/2 for induction and CRT. Dose level 2 was expanded. The overall survival CR rate after CRT was 79 percent. Median overall (OS) has not been reached and 2-year OS is 80.7 percent. The recommended Phase II dose of docetaxel with FHX CRT is 25 mg/m(2) and 35 mg/m(2) in combination with carboplatin induction (AUC = 6).

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / radiotherapy
  • Docetaxel
  • Female
  • Fluorouracil / administration & dosage
  • Head and Neck Neoplasms / drug therapy*
  • Head and Neck Neoplasms / radiotherapy
  • Humans
  • Hydroxyurea / administration & dosage
  • Male
  • Maximum Tolerated Dose*
  • Middle Aged
  • Survival Analysis
  • Taxoids / administration & dosage*
  • Taxoids / adverse effects

Substances

  • Taxoids
  • Docetaxel
  • Fluorouracil
  • Hydroxyurea