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Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer

Gastric cancer is one of the leading causes of cancer death in Taiwan. We have previously
demonstrated that weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin
is an effective and well-tolerated regimen for patients with advanced gastric cancer. Our in
vitro and clinical studies suggested that long (24 hours or more) infusion of
5-FU/leucovorin may, compared with the conventional bolus regimens, enhance its anti-tumor
activity in gastric cancer by prolonging suppression of thymidylate synthase, the target
enzyme of 5-FU cytotoxicity. Docetaxel, a mitotic inhibitor, has good single-agent activity
against gastric cancer, with a tumor response rate around 20 to 24%. Preliminary clinical
data indicate that a biweekly administration of docetaxel will reduce the incidence of
neutropenia and asthenia, two most bothersome side effects of tri-weekly and weekly
docetaxel, respectively, while maintaining its anti-tumor activity. This phase II trial is
designed to test the efficacy and toxicity of biweekly docetaxel and 24-hour infusion of
high-dose 5-FU/leucovorin as first-line therapy for patients with inoperable advanced
gastric cancer.

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% (see Appendix)

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

7. Serum triglyceride level>70mg/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

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 of 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:

tumor response rate

Principal Investigator

Ann-Lii Cheng

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oncology , National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

June 2004

Completion Date:

July 2005

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms