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

August 14, 2008 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Department of Oncology, Nationa Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
tumor response rate

Secondary Outcome Measures

Outcome Measure
clinical benefit response, toxicities, quality of life, time to disease progression, overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Ann-Lii Cheng, Department of Oncology , National Taiwan University Hospital
  • Principal Investigator: Ann-Lii Cheng, Department of Oncology, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Anticipated)

July 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

July 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 921101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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