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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

Phase 2
18 Years
75 Years
Not Enrolling
Stomach Neoplasms

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Trial Information

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.

Inclusion Criteria:

- 1.Histologically proven and inoperable advanced gastric adenocarcinoma.
2.Bi-dimensionally measurable disease by physical examination or image study
(roentgenogram or computed tomography scan). The index lesions should be at least 20
mm × 10 mm in size. 3.Age must be older than 18 and younger than 75 year-old.
4.Karnofsky performance status 60%. 5.Adequate bone marrow reserves, defined as white
blood cell (WBC) 4,000/l, absolute neutrophil count (ANC)1,500/l, platelet 100,000/l.
6.Liver transaminases 2.5 times upper normal limit if no liver metastasis and 5 times
upper normal limit if liver metastasis is present; total bilirubin 1.5 mg/dl; serum
creatinine 1.5 mg/dl. 7.Serum triglyceride level 70 mg/dl. 8.Previous chemotherapy
for metastatic disease is not allowed in this study. Previous adjuvant chemotherapy
following curative gastrectomy is acceptable if the adjuvant chemotherapy has been
completed for more than 6 months before enrollment into the present study. 9.Previous
radiotherapy is allowed if the treatment was completed at least 4 weeks before the
enrollment into this study. 10.Patients of childbearing age should have effective
contraception during the study period. 11.All patients must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional guidelines.

Exclusion Criteria:

- 1.Patients who are receiving concurrent radiotherapy, chemotherapy or other
experimental therapy. 2.Patients who refuse port-A catheter implantation. 3.Patients
with brain or leptomeningeal metastases. 4.Patients who have significant cardiac
arrhythmia or acute myocardial infarction within 6 months before entry. 5.Patients
who have major systemic diseases that the attending physicians considered
inappropriate for systemic chemotherapy. 6.Life expectancy less than 2 months.
7.Pregnant or nursing women may not participate. Women or men with reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method. 8.No other prior malignancy is allowed except for the
following: adequately treated basal cell or squamous cell skin cancers, in situ
cervical cancer, adequately treated stage I or II cancer from which the patient is
currently in complete remission, or any cancer from which the patient has been
disease-free for 5 years.

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of

Principal Investigator

Kun Huei Yeh, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Far Eastern Memorial Hospital


Taiwan: Department of Health

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms