NCT00037089

Brief Summary

This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to:

  1. 1.Determine how well a combination of taxol, UFT, and leucovorin work in these patients,
  2. 2.Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs.
  3. 3.Identify the side effects of this drug combination.

Trial Health

55
Monitor

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 14, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2002

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2005

First QC Date

May 14, 2002

Last Update Submit

June 23, 2005

Conditions

Esophageal Neoplasm

Interventions

UFT (Tegafur/Uracil)DRUG

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic proof of esophageal cancer
  • No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND they may not have received a regimen containing low dose continuous infusion of 5-FU (i.e. \>5 days of infusion/cycle), capecitabine or UFT
  • No prior therapy with UFT+/-leucovorin, a taxane, capecitabine, low dose continuous infusion of 5-FU or ethynyl uracil.
  • Radiographic or physical examination documentation of metastatic disease
  • No major surgery within the 2 weeks preceding the start of treatment and fully recovered from any complications of surgery
  • No radiation within 2 weeks of beginning chemotherapy.
  • No chemotherapy within 4 weeks of beginning treatment.
  • Patients must wait at least 6 weeks after receiving BCNU or Mitomycin-C.
  • Minimum life expectancy of 3 months
  • Informed consent given
  • Laboratory values within limits set by study.

You may not qualify if:

  • More than one prior chemotherapy regimen for metastatic disease
  • Current serious medical or psychiatric illness that would prevent informed consent or intensive treatment
  • \>grade 1 peripheral sensory or motor neuropathy
  • Pregnant
  • Patient is taking the drug Sorivudine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

TegafurUracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FluorouracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDIV

Study Record Dates

First Submitted

May 14, 2002

First Posted

May 15, 2002

Last Updated

June 24, 2005

Record last verified: 2005-01

Locations

US(1)