Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer
July 30, 2007 updated by: National Taiwan University Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Department of Oncology, Nationa Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To evaluate the response rate
Time Frame: 2003~2004
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2003~2004
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine time to progression and safety
Time Frame: 2004~2005
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2004~2005
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kun-Huei Yeh, M.D.,Ph.D., Department of Oncology, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
July 31, 2007
Last Update Submitted That Met QC Criteria
July 30, 2007
Last Verified
July 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 910703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.