A Phase II Study of Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin(HDFL)for Inoperable Advanced or Metastatic Gastric Cancer
The regimen consists of docetaxel, 50 mg/m2, 5-FU, 2400 mg/m2, and leucovorin, 240 mg/m2 on
days 1 and 15. Docetaxel will be given by 1-hour intravenous infusion and 5-FU/leucovorin by
24-hour intravenous infusion.
The treatment cycle will be repeated every 4 weeks. Dexamethasone will be given before and
after each docetaxel infusion to prevent hypersensitivity and fluid retention. Tumor
response will be evaluated every 2 cycles. For patients with inoperable locally advanced
disease on entry, those who achieve clinical complete (CR) and partial (PR) response will be
evaluated for the feasibility of curative surgical resection.If pathological CR is
documented, at least 2 cycles of chemotherapy will be given after surgery. If microscopic
residual tumor is noted after curative surgery, protocol treatment will be continued until
disease progresses or intolerable toxicities develop. For patients with metastatic diseases
on entry, those who achieve CR will receive at least 2 more cycles of chemotherapy after
documentation of CR. Patients with PR will continue protocol treatment until disease
progresses or intolerable toxicities develop. Patients with stable disease will continue
protocol treatment if there are minor tumor responses or improvement of their general
condition; patients will stop protocol treatment and change to salvage therapy if no any
clinical benefits are observed. Patients with progressive disease should stop protocol
treatment and change to salvage therapy.
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.If 5 or more objective responses are documented in the
first 19 patients, the study will go on to the second stage to enroll a total of 54 eligible
patients. The P0, P1,are 20%, 40%, 0.05, and 0.1, respectively. Assuming a dropout rate of
10%, 21 patients will be accrued in the first stage and 39 in the second stage. Estimated
time for patient accrual is 3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of
Kun Huei Yeh, Ph.D.
Far Eastern Memorial Hospital
Taiwan: Department of Health