Gastric CancerPhase 2NCT00155883
Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer
A Phase 2 study testing Taxteral, 5-Fluorouracil and Leucovorin in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Taxteral, 5-Fluorouracil and Leucovorin
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2004to Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven and inoperable advanced gastric adenocarcinoma.
- Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography scan). The index lesions should be at least 20 mm × 10 mm in size.
- Age must be older than 18 and younger than 75 year-old.
- Karnofsky performance status>60% (see Appendix)
- Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/l, absolute neutrophil count (ANC)>1,500/l, platelet>100,000/l.
- Liver transaminases <2.5 times upper normal limit if no liver metastasis and 5 times upper normal limit if liver metastasis is present; total bilirubin <1.5 mg/dl; serum creatinine<1.5mg/dl.
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- Serum triglyceride level>70mg/dl.
- Previous chemotherapy for metastatic disease is not allowed in this study. Previous adjuvant chemotherapy following curative gastrectomy is acceptable if the adjuvant chemotherapy has been completed for more than 6 months before enrollment into the present study.
- Previous radiotherapy is allowed if the treatment was completed at least 4 weeks before the enrollment into this study.
- Patients of childbearing age should have effective contraception during the study period.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.
Who cannot join
- Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
- Patients who refuse port-A catheter implantation.
- Patients with brain or leptomeningeal metastases.
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
- Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
- Life expectancy of less than 2 months.
- Pregnant or nursing women may not participate. Women or men with reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable advanced gastric cancer.
Read the detailed description
Gastric cancer is one of the leading causes of cancer death in Taiwan. We have previously demonstrated that weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin is an effective and well-tolerated regimen for patients with advanced gastric cancer. Our in vitro and clinical studies suggested that long (24 hours or more) infusion of 5-FU/leucovorin may, compared with the conventional bolus regimens, enhance its anti-tumor activity in gastric cancer by prolonging suppression of thymidylate synthase, the target enzyme of 5-FU cytotoxicity. Docetaxel, a mitotic inhibitor, has good single-agent activity against gastric cancer, with a tumor response rate around 20 to 24%. Preliminary clinical data indicate that a biweekly administration of docetaxel will reduce the incidence of neutropenia and asthenia, two most bothersome side effects of tri-weekly and weekly docetaxel, respectively, while maintaining its anti-tumor activity. This phase II trial is designed to test the efficacy and toxicity of biweekly docetaxel and 24-hour infusion of high-dose 5-FU/leucovorin as first-line therapy for patients with inoperable advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Taxteral, 5-Fluorouracil, Leucovorin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxteralDrug
5-FluorouracilDrug
LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
Secondary outcomes (1)
clinical benefit response, toxicities, quality of life, time to disease progression, 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 startJun 2004
- Study completionJul 2005 (estimated)
Why it stopped: slow a accrul due to many competitive trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ann-Lii Cheng, Study chair, Department of Oncology , National Taiwan University HospitalAnn-Lii Cheng, Principal investigator, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155883
- Sponsor's protocol ID
- 921101
- Status last verified
- Jul 2005
- First submitted
- 9 Sep 2005
- Last updated
- 18 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00155883
- Acronym / sponsor ID
- 921101
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow a accrul due to many competitive trials.
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Jul 2005 (estimated)
- 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 primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable advanced gastric cancer.
Detailed description
Gastric cancer is one of the leading causes of cancer death in Taiwan. We have previously demonstrated that weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin is an effective and well-tolerated regimen for patients with advanced gastric cancer. Our in vitro and clinical studies suggested that long (24 hours or more) infusion of 5-FU/leucovorin may, compared with the conventional bolus regimens, enhance its anti-tumor activity in gastric cancer by prolonging suppression of thymidylate synthase, the target enzyme of 5-FU cytotoxicity. Docetaxel, a mitotic inhibitor, has good single-agent activity against gastric cancer, with a tumor response rate around 20 to 24%. Preliminary clinical data indicate that a biweekly administration of docetaxel will reduce the incidence of neutropenia and asthenia, two most bothersome side effects of tri-weekly and weekly docetaxel, respectively, while maintaining its anti-tumor activity. This phase II trial is designed to test the efficacy and toxicity of biweekly docetaxel and 24-hour infusion of high-dose 5-FU/leucovorin as first-line therapy for patients with inoperable advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven and inoperable advanced gastric adenocarcinoma.
- Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography scan). The index lesions should be at least 20 mm × 10 mm in size.
- Age must be older than 18 and younger than 75 year-old.
- Karnofsky performance status>60% (see Appendix)
- Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/l, absolute neutrophil count (ANC)>1,500/l, platelet>100,000/l.
Key exclusion criteria (8 listed)
- Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
- Patients who refuse port-A catheter implantation.
- Patients with brain or leptomeningeal metastases.
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
- Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
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 |
|---|---|---|
| Taxteral | Drug | – |
| 5-Fluorouracil | Drug | – |
| Leucovorin | Drug | – |
Primary outcome
tumor response rate
1 secondary outcome
clinical benefit response, toxicities, quality of life, time to disease progression, overall survival
Results and safety
The study was stopped early (reason given: slow a accrul due to many competitive trials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
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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 study chair
Department of Oncology , National Taiwan University Hospital
Ann-Lii Cheng principal investigator
Department of Oncology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taxteral, 5-Fluorouracil and Leucovorin in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: slow a accrul due to many competitive trials.). Results are not available in the source record.
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?
tumor 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 18 Aug 2008.