NCT00154700

Brief Summary

The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy.

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 Jan 2001

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

January 1, 2001

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 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

December 20, 2005

Status Verified

July 1, 2005

First QC Date

September 8, 2005

Last Update Submit

December 19, 2005

Conditions

Esophageal Cancer

Keywords

Combination,Chemotherapy,Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (3)

  • Overall survival

  • Progression-free survival

  • Toxicity

Interventions

Paclitaxel,Cisplatin,5-Fu,Folic AcidDRUG

Eligibility Criteria

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

You may qualify if:

  • Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or metastasis Measurable disease (\> 1 X 1 cm) by CXR, CT scan or MRI,Age \> 18, KPS \> 60% , Cre \< 1.5mg/dl, AST/ALT \< 3.5 X N, Bil \< 2.0mg/dl WBC \> 4,000/mm3, ANC \> 2,000/ mm3, Plt \> 100,000/mm3

You may not qualify if:

  • Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except \> 2 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

Esophageal Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Ann-Lii Cheng, M.D., Ph.D.

    Department of Oncology, National Taiwan University hospital

    STUDY CHAIR

  • 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
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2001

Study Completion

July 1, 2005

Last Updated

December 20, 2005

Record last verified: 2005-07

Locations

TW(1)