Eleven patients with chemotherapeutically pretreated advanced gastric
cancer were treated in a phase II study with a combination of 5-fluoro
uracil (5-FU) and Leucovorin (LV, folinic acid). 5-FU (1,200 mg/m(2))
and LV (100 mg/m(2)) were given as a parallel continuous intravenous i
nfusion over 48 h every 2 weeks for at least 8 weeks. Toxicity and res
ponse rates were evaluated. Results show that this chemotherapeutic re
gimen is well tolerable, without any side effects exceeding WHO grade
1 toxicity, but that it has no considerable effects on tumor growth. N
one of the patients achieved disease remission. In 8 out of the 11 stu
dy patients therapy had to be discontinued prematurely because of dise
ase progression. Therefore we conclude that the studied protocol of 5-
FU/LV as second-line treatment of advanced gastric cancer although wel
l tolerable is not effective.