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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Taxol, UFT,Leucovorin
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Combination,Chemotherapy,Advanced Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, Nationa Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the response rate

Secondary Outcome Measures

To determine time to progression and safety

Full Information

First Posted
September 8, 2005
Last Updated
July 30, 2007
Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00154778
Brief Title
Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Combination,Chemotherapy,Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Taxol, UFT,Leucovorin
Primary Outcome Measure Information:
Title
To evaluate the response rate
Time Frame
2003~2004
Secondary Outcome Measure Information:
Title
To determine time to progression and safety
Time Frame
2004~2005

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun-Huei Yeh, M.D.,Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Nationa Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
16804524
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Search&db=PubMed&term=16804524
Description
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.

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

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