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
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
- —
- Primary completion
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- Completion
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 240 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |