Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer
Gastric cancer is one of the leading causes of cancer death in Taiwan. We have previously
demonstrated that weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin
is an effective and well-tolerated regimen for patients with advanced gastric cancer. Our in
vitro and clinical studies suggested that long (24 hours or more) infusion of
5-FU/leucovorin may, compared with the conventional bolus regimens, enhance its anti-tumor
activity in gastric cancer by prolonging suppression of thymidylate synthase, the target
enzyme of 5-FU cytotoxicity. Docetaxel, a mitotic inhibitor, has good single-agent activity
against gastric cancer, with a tumor response rate around 20 to 24%. Preliminary clinical
data indicate that a biweekly administration of docetaxel will reduce the incidence of
neutropenia and asthenia, two most bothersome side effects of tri-weekly and weekly
docetaxel, respectively, while maintaining its anti-tumor activity. This phase II trial is
designed to test the efficacy and toxicity of biweekly docetaxel and 24-hour infusion of
high-dose 5-FU/leucovorin as first-line therapy for patients with inoperable advanced
gastric cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
tumor response rate
Ann-Lii Cheng
Study Chair
Department of Oncology , National Taiwan University Hospital
Taiwan: Department of Health
921101
NCT00155883
June 2004
July 2005
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