An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer

Br J Cancer. 2006 Jul 17;95(2):159-63. doi: 10.1038/sj.bjc.6603225. Epub 2006 Jun 27.

Abstract

The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (Taxol((R))) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m(-2) on days 1 and 8 and oral UFT 300 mg m(-2) day(-1) plus LV 90 mg day(-1) were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50% (95% confidence interval: 35-65%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45%) and diarrhoea in eight patients (15%). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16%), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Combined Modality Therapy
  • Disease Progression
  • Disease-Free Survival
  • Drug Administration Schedule
  • Drug Combinations
  • Female
  • Humans
  • Leucovorin / adverse effects*
  • Leucovorin / therapeutic use
  • Male
  • Middle Aged
  • Paclitaxel / adverse effects*
  • Paclitaxel / therapeutic use
  • Prospective Studies
  • Safety
  • Stomach Neoplasms / drug therapy*
  • Survival Rate
  • Tegafur / adverse effects
  • Tegafur / therapeutic use
  • Treatment Outcome
  • Uracil / adverse effects
  • Uracil / therapeutic use

Substances

  • Drug Combinations
  • Tegafur
  • Uracil
  • Paclitaxel
  • Leucovorin

Supplementary concepts

  • 1-UFT protocol