Clinical trial · Interventional
Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer
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
NCT00154778CI-TRIAL-00000813completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taxol, UFT,Leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Taxol, UFT,Leucovorin
Primary outcomes (1)
- measure
- To evaluate the response rate
- timeFrame
- 2003~2004
Secondary outcomes (1)
- measure
- To determine time to progression and safety
- timeFrame
- 2004~2005
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChao 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. PMID 16804524