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Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer

NCT ID: NCT00154778

Last Updated: 2007-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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

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Gastric Cancer

Keywords

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Combination,Chemotherapy,Advanced Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Taxol, UFT,Leucovorin

Intervention Type DRUG

Interventions

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Taxol, UFT,Leucovorin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years old
2. Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease
3. Patients with at least one measurable lesion
4. ECOG performance status of 0,1 or 2
5. 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)
6. 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
7. Accessible for treatment and follow-up
8. Give written informed consent
9. 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

1. Patients who received surgery within 14 days prior to enrollment
2. Patients with CNS metastasis
3. 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.)
4. Patients with a history of severe hypersensitivity
5. Active infectious symptoms
6. Patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication
7. Patients with ascites that adversely affects performance status
8. Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory)
9. Pregnant or nursing females
10. Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Kun-Huei Yeh, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, National Taiwan University Hospital

Locations

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Department of Oncology, Nationa Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 16804524 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Search&db=PubMed&term=16804524

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.

Other Identifiers

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910703

Identifier Type: -

Identifier Source: org_study_id