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OpenTrials
Completed

NCT Number: NCT00154726

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Paclitaxel-HDFL

Drug

Primary outcomes

  1. Response rate

Secondary outcomes

  1. overall survival

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
1997
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Nov 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.