A phase I study of combination chemotherapy with gemcitabine and oral UFT for advanced non-small cell lung cancer

Br J Cancer. 2002 Jun 5;86(11):1701-4. doi: 10.1038/sj.bjc.6600337.

Abstract

A phase I study was carried out to determine the optimal dose and administration schedule for combined UFT plus gemcitabine therapy in patients with non-small cell lung cancer. Twenty-four patients (including 11 patients previously treated with cisplatin as the key drug) received oral UFT 400 mg x m(-2) on days 1 to 14 with intravenous infusions of gemcitabine (800 mg x m(-2) on days 8 and 15, or 900 mg x m(-2) on days 8 and 15, or 900 mg x m(-2) on days 1, 8 and 15). The most appropriate dosing option appeared to be 400 mg x m(-2) per day of oral UFT for 14 consecutive days with 900 mg x m(-2) gemcitabine on days 8 and 15. Eight of the 24 patients achieved partial response. The combination chemotherapy UFT and gemcitabine was well tolerated and may benefit patients with advanced non-small cell lung cancer. A multicentre phase II study using a 3-weekly regimen is in progress.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Administration, Oral
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects*
  • Deoxycytidine / analogs & derivatives*
  • Fever / chemically induced
  • Gemcitabine
  • Hematologic Diseases / chemically induced
  • Humans
  • Kidney / drug effects
  • Kidney / pathology
  • Liver / drug effects
  • Liver / pathology
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Nausea / chemically induced
  • Neoplasm Staging
  • Tegafur / adverse effects*
  • Uracil / adverse effects*

Substances

  • Deoxycytidine
  • Tegafur
  • Uracil
  • Gemcitabine

Supplementary concepts

  • 1-UFT protocol