Gastric CancerPhase 2NCT00154778
Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer
A Phase 2 study testing Taxol, UFT,Leucovorin in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Taxol, UFT,Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2003to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease
- Patients with at least one measurable lesion
- ECOG performance status of 0,1 or 2
- Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded)
- Patients with physiological functions (bone marrow, heart, liver, kidney, etc.) meeting the following criteria: WBC >4000/mm3, ANC >1500/mm3, PLT >100,000/mm3, Hb >9.0g/dL, ALT<3 times the ULN (<5 times the ULN for liver metastasis cases), Total bilirubin <1.5mg/dL, Creatinine <the upper limit of normal
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- Accessible for treatment and follow-up
- Give written informed consent
- Women of child bearing potential must have a negative plasma or urine pregnancy test within 72 hours prior to start of the study medication
Who cannot join
- Patients who received surgery within 14 days prior to enrollment
- Patients with CNS metastasis
- History of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.)
- Patients with a history of severe hypersensitivity
- Active infectious symptoms
- Patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication
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- Patients with ascites that adversely affects performance status
- Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory)
- Pregnant or nursing females
- Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Oncology, Nationa Taiwan University Hospital
Taipei, Taipei, 100
About this study
Official title: An Open,Multi-Center,Phase II Clinical Trial tO Evaluate Efficacy and Safety oF TAXOL(PACLITAXEL),UFT,and LEUCOVORIN in Patients With Advanced Gastric Cancer
The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.
Read the detailed description
Since 1982,cancer has been the leading cause of death in Taiwan. In particular,gastric cancer is the fourth leading cause of death in male cancer patients and the sixth for female patients in 2000,accounting for an estimated 2,374 deaths. In recent years, the treatment of gastric cancer patients has gradually been improving due to advances in early diagnosis and surgical techniques. Although chemotherapy and radiation therapy have been used in either the adjuvant or palliative setting, their values are still limited due to their unacceptable toxicity or inadequate efficiency.
- Conditions
- Gastric Cancer
- Being tested
- Taxol, UFT,Leucovorin
- Keywords
- Combination,Chemotherapy,Advanced Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxol, UFT,LeucovorinDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Taxol, UFT,Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the response rate
Measured: 2003~2004
Secondary outcomes (1)
To determine time to progression and safety
Measured: 2004~2005
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 startMar 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Health Research Institutes, Taiwan
- Investigators
- Kun-Huei Yeh, M.D.,Ph.D., Principal investigator, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154778
- Sponsor's protocol ID
- 910703
- Status last verified
- Jul 2005
- First submitted
- 8 Sep 2005
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chao Y, Li CP, Chao TY, Su WC, Hsieh RK, Wu MF, Yeh KH, Kao WY, Chen LT, Cheng AL. An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer. Br J Cancer. 2006 Jul 17;95(2):159-63. doi: 10.1038/sj.bjc.6603225. Epub 2006 Jun 27.
PubMed 16804524
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open,Multi-Center,Phase II Clinical Trial tO Evaluate Efficacy and Safety oF TAXOL(PACLITAXEL),UFT,and LEUCOVORIN in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00154778
- Acronym / sponsor ID
- 910703
- Conditions
- Gastric Cancer
- Keywords
- Combination,Chemotherapy,Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Health Research Institutes, Taiwan
- Study start
- Mar 2003
- Study completion
- Jun 2005 (actual)
- 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 response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.
Detailed description
Since 1982,cancer has been the leading cause of death in Taiwan. In particular,gastric cancer is the fourth leading cause of death in male cancer patients and the sixth for female patients in 2000,accounting for an estimated 2,374 deaths. In recent years, the treatment of gastric cancer patients has gradually been improving due to advances in early diagnosis and surgical techniques. Although chemotherapy and radiation therapy have been used in either the adjuvant or palliative setting, their values are still limited due to their unacceptable toxicity or inadequate efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Taxol, UFT,Leucovorin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old
- Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease
- Patients with at least one measurable lesion
- ECOG performance status of 0,1 or 2
- Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded)
Key exclusion criteria (10 listed)
- Patients who received surgery within 14 days prior to enrollment
- Patients with CNS metastasis
- History of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.)
- Patients with a history of severe hypersensitivity
- Active infectious symptoms
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 |
|---|---|---|
| Taxol, UFT,Leucovorin | Drug | A |
Primary outcome
To evaluate the response rate
Time frame: 2003~2004
1 secondary outcome
To determine time to progression and safety
Time frame: 2004~2005
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 31 Jul 2007.
- Results publication: PubMed 16804524Chao Y, Li CP, Chao TY, Su WC, Hsieh RK, Wu MF, Yeh KH, Kao WY, Chen LT, Cheng AL. An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer. Br J Cancer. 2006 Jul 17;95(2):159-63. doi: 10.1038/sj.bjc.6603225. Epub 2006 Jun 27.
- An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer.Link provided by the sponsor.
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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.
Kun-Huei Yeh, M.D.,Ph.D. 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 Taxol, UFT,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 9 inclusion and 10 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: finished, as of the sponsor's last update on 31 Jul 2007. 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 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?
To evaluate the response rate (time frame: 2003~2004). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00154778, which also lists 1 linked publication.
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 31 Jul 2007.