Locally Advanced and Recurrent/Metastatic Gastric CancerPhase 2NCT00154726
Paclitaxel-HDFL for Locally Advanced and Recurrent/Metastatic Gastric Cancers
A Phase 2 study testing Paclitaxel-HDFL in people with Locally Advanced and Recurrent/Metastatic Gastric Cancer, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced and Recurrent/Metastatic Gastric Cancer
- What is being tested?
- Paclitaxel-HDFL
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 1997to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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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About this 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
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
Read the 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.
- Being tested
- Paclitaxel-HDFL
- Keywords
- Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer
- Medical subject headings
- Recurrence, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-HDFLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (1)
overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 1997
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced and Recurrent/Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ann-Lii Cheng, M.D.,Ph.D., Study chair, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154726
- Sponsor's protocol ID
- 36-3
- Status last verified
- Aug 2005
- First submitted
- 8 Sep 2005
- Last updated
- 22 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00154726
- Acronym / sponsor ID
- 36-3
- Keywords
- Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 1997
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel-HDFL | Drug | – |
Primary outcome
Response rate
1 secondary outcome
overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Lii Cheng, M.D.,Ph.D. study chair
Department of Oncology, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel-HDFL in people with Locally Advanced and Recurrent/Metastatic Gastric Cancer, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2005.