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| Sponsored by: |
National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00154726 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Locally Advanced and Recurrent/Metastatic Gastric Cancer |
Drug: Paclitaxel-HDFL |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1997 |
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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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Contacts and Locations More Information
| Study ID Numbers: | 36-3 |
| Study First Received: | September 8, 2005 |
| Last Updated: | November 21, 2005 |
| ClinicalTrials.gov Identifier: | NCT00154726 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Leucovorin Antimitotic Agents Recurrence Digestive System Diseases Stomach Diseases |
Paclitaxel Stomach Neoplasms Fluorouracil Tubulin Modulators Gastrointestinal Neoplasms Stomach Cancer Antineoplastic Agents, Phytogenic |
|
Disease Attributes Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Mitosis Modulators Antimitotic Agents Pharmacologic Actions Recurrence Neoplasms |
Neoplasms by Site Digestive System Diseases Stomach Diseases Pathologic Processes Paclitaxel Therapeutic Uses Stomach Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |
