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
18 Years
70 Years
Both
Locally Advanced and Recurrent/Metastatic Gastric Cancer
Trial Information
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
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.
Inclusion Criteria:
1.Histologically or cytologically confirmed gastric adenocarcinoma2.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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Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Principal Investigator
Ann-Lii Cheng, M.D.,Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Oncology, National Taiwan University Hospital
Authority:
Taiwan: Department of Health
Study ID:
36-3
NCT ID:
NCT00154726
Start Date:
April 1997
Completion Date:
August 2005
Related Keywords:
- Locally Advanced and Recurrent/Metastatic Gastric Cancer
- Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer
- Stomach Neoplasms
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