NCT00154778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

July 31, 2007

Status Verified

July 1, 2005

First QC Date

September 8, 2005

Last Update Submit

July 30, 2007

Conditions

Gastric Cancer

Keywords

Combination,Chemotherapy,Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the response rate

    2003~2004

Secondary Outcomes (1)

  • To determine time to progression and safety

    2004~2005

Study Arms (1)

A

EXPERIMENTAL
Drug: Taxol, UFT,Leucovorin

Interventions

Taxol, UFT,LeucovorinDRUG
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Nationa Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 16804524RESULT

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Kun-Huei Yeh, M.D.,Ph.D.

    Department of Oncology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Study Completion

June 1, 2005

Last Updated

July 31, 2007

Record last verified: 2005-07

Locations

TW(1)