NCT00154687

Brief Summary

The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2000

Typical duration for phase_2

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

October 1, 2000

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 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

Transitional Cell Carcinoma

Keywords

Combination, Chemotherapy,transitional cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • response rate

    2000~2005

Secondary Outcomes (1)

  • Overall Survival ,Safety

    2000~2005

Study Arms (1)

A

EXPERIMENTAL
Drug: Paclitaxel, Cisplatin, 5-Fluorouracil

Interventions

Paclitaxel, Cisplatin, 5-FluorouracilDRUG
A

Eligibility Criteria

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

You may qualify if:

  • Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC
  • Measurable disease
  • Age\>18
  • KPS\>60﹪
  • Creatinine clearance\>35ml/min,
  • AST/ALT \< or = 3.5times upper limits of normal reference values
  • Bilirubin\< or = 2.0 mg/dl
  • WBC \> or = 4,000/mm3, PLT \> or = 100,000/mm3
  • Written informed consent

You may not qualify if:

  • Previous systemic chemo is not allowed
  • TG \<70mg/dl
  • CNS metastasis
  • Life expectancy less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

PaclitaxelCisplatinFluorouracil

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chih-Hung Hsu, M.D.,Ph.D.

    Department of Oncology , National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Ann-Lii Cheng, M.D.,Ph.D

    Department of Oncology, National Taiwan University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2000

Study Completion

December 1, 2004

Last Updated

July 31, 2007

Record last verified: 2005-07

Locations

TW(1)