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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00155883
Recruitment Status : Terminated (slow a accrul due to many competitive trials.)
First Posted : September 12, 2005
Last Update Posted : August 18, 2008
Information provided by:
National Taiwan University Hospital

Brief Summary:
The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Taxteral Drug: 5-Fluorouracil Drug: Leucovorin Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer
Study Start Date : June 2004
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. tumor response rate

Secondary Outcome Measures :
  1. clinical benefit response, toxicities, quality of life, time to disease progression, overall survival

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 creatinine<1.5mg/dl.
  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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00155883

Department of Oncology, Nationa Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Ann-Lii Cheng Department of Oncology , National Taiwan University Hospital
Principal Investigator: Ann-Lii Cheng Department of Oncology, National Taiwan University Hospital Identifier: NCT00155883     History of Changes
Other Study ID Numbers: 921101
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: July 2005

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs