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

Stomach Neoplasms Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

• NCT number: NCT00270543
• Study type: Interventional
• Source: Far Eastern Memorial Hospital
• Contact: Kun Huei Yeh, Ph.D.
• Phone: 886-2-89667000
• Email: khyeh@mail.femh.org.tw
• Status: Not yet recruiting
• Phase: Phase 2