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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00037089
Recruitment Status : Unknown
Verified January 2005 by Edelman, Martin, M.D..
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2002
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Edelman, Martin, M.D.

Brief Summary:

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

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

Condition or disease Intervention/treatment Phase
Esophageal Neoplasm Drug: UFT (Tegafur/Uracil) Phase 2

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037089


Locations
United States, Maryland
University of Maryland Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Edelman, Martin, M.D.
Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT00037089     History of Changes
Other Study ID Numbers: BMS-200604
UMCC 0110g
First Posted: May 15, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2005

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents