drugset / Trial / NCT00270543

An Effective and Well-Tolerated Regimen of Docetaxel Plus High-Dose 5-Fluorouracil and Leucovorin(HDFL)to Treat Inoperable Advanced or Metastatic Gastric Cancer

NCT00270543 ↗

Phase 2 Unknown 54 enrolled Far Eastern Memorial Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary endpoint of this phase II trial is the objective tumor response rate. The secondary endpoints include treatment-related toxicity, the clinical benefit response defined by the change in performance status and body weight, the change in quality of life, progression free survival and overall survival. Simon's optimal two-stage design will be used to determine the patient number.

Timeline

Start
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Primary completion
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Completion
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Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Leucovorin Small molecule 240 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications