A Phase II Study of Biweekly Oxaliplatin and 5-Fluorouracil/Leucovorin Combination Chemotherapy (FOLFIRI) in Patients With Advanced Gastric Cancer (AGC) With Failure of Prior Chemotherapy Including Taxane, Fluoropyrimidine and Cisplatinum
There is presently no chemotherapy regimen considered to be the standard of care for
patients with advanced gastric cancer. However, more and more patients will receive
fluoropyrimidine, platinum, and taxane combination or sequential chemotherapy.
Unfortunately, about half of the patients receiving chemotherapy are unresponsive and
treatment results of salvage chemotherapy are unsatisfactory. For these patients, there are
currently no established palliative chemotherapy options, and there is urgent need for
novel, active, and less toxic regimens for patients with advanced gastric cancer failing
front-line chemotherapy.
On these bases, we will investigate the activity of biweekly oxaliplatin and 5-FU/LV in
patients with advanced gastric cancer who failed prior taxane, fluoropyrimidine and
cisplatin chemotherapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
4 months
No
Korea: Food and Drug Administration
AMC0501
NCT00976768
October 2004
December 2009
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