Paclitaxel-HDFL for Locally Advanced and Recurrent/Metastatic Gastric Cancers

A Phase II Study of Weekly Paclitaxel(Taxol)and 24-Hour Infusion High-Dose 5-Fluorouracil and Leucovorin(HDFL)in the Treatment Locally Advanced and Recurrent/Metastatic Gastric Cancers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154726

Enrollment

Registered

2005-09-12

Start date

1997-04-30

Completion date

2005-08-31

Last updated

2005-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced and Recurrent/Metastatic Gastric Cancer

Keywords

Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer

Brief summary

The purpose of this study is to evaluate the efficacy,response rate,time to treatment failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen

Detailed description

In the treatment of metastatic breast cancer, paclitaxel followed by weekly HDFL has been shown to have a 55% response rate in anthracycline-resistant patient. Recently, regimen combining paclitaxel and moderately-high-dose 5-FU (1500mg/m2) has had response rate up to 61.5% (including 23%CR) in a small group of gastric cancer patients (8 responders in 13 patients). Thus, the sequential use of weekly paclitaxel followed by weekly HDFL regimen may become a new generation of chemotherapeutic regimen for the treatment of gastric cancer. Further study with a larger group of patients and further testing of possible schedules of administration are warranted.

Interventions

DRUGPaclitaxel-HDFL

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1.Histologically or cytologically confirmed gastric adenocarcinoma 2.Measurable or evaluable disease 3.No previous C/T 4.Age 18 \ 70 years 5.KPS \>=60% 6.WBC\>=4,000, pltate\>=100K, Creatinine\<=1.5mg/dl, serum bil\<=1x UNL, transaminase\<=3.5x ULN

Exclusion criteria

1.CNS metastasis 2.Patients receive concomitant anti-cancer C/T or R/T 3.Patients who are pregnant and with an expected life expectancy less than 3months 4.Symptomatic heart disease,active infection, extensive liver disease or liver cirrhosis 5.TG\<=70mg/dl 6.Mental status is not fit for clinical trial \-

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
overall survival	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026