Status:
COMPLETED
Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,acc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00154778
Start Date
March 1 2003
End Date
June 1 2005
Last Update
July 31 2007
Active Locations (1)
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1
Department of Oncology, Nationa Taiwan University Hospital
Taipei, Taipei, Taiwan, 100