search
Back to results

A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer

Primary Purpose

Esophageal Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
UFT (Tegafur/Uracil)
Sponsored by
Edelman, Martin, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasm

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION 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. EXCLUSION 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

Sites / Locations

  • University of Maryland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 14, 2002
Last Updated
June 23, 2005
Sponsor
Edelman, Martin, M.D.
Collaborators
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00037089
Brief Title
A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Edelman, Martin, M.D.
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to: Determine how well a combination of taxol, UFT, and leucovorin work in these patients, Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs. Identify the side effects of this drug combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
UFT (Tegafur/Uracil)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION 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. EXCLUSION 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
Facility Information:
Facility Name
University of Maryland Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer

We'll reach out to this number within 24 hrs