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Sponsored by: |
Far Eastern Memorial Hospital |
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Information provided by: | Far Eastern Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00270543 |
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.
Condition | Intervention | Phase |
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Stomach Neoplasms |
Drug: Taxotere, Fluorouracil, Leucovorin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 54 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kun Huei Yeh, Ph.D. | 886-2-89667000 ext 1611 | khyeh@mail.femh.org.tw |
Principal Investigator: | Kun Huei Yeh, Ph.D. | Far Eastern Memorial Hospital |
Study ID Numbers: | FEMH-93006 |
Study First Received: | December 26, 2005 |
Last Updated: | December 26, 2005 |
ClinicalTrials.gov Identifier: | NCT00270543 |
Health Authority: | Taiwan: Department of Health |
Docetaxel Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Fluorouracil Stomach Neoplasms Leucovorin Gastrointestinal Neoplasms Stomach cancer |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |