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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by Edelman, Martin, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Edelman, Martin, M.D.
ClinicalTrials.gov Identifier:
NCT00037089
First received: May 14, 2002
Last updated: June 23, 2005
Last verified: January 2005
History of Changes
  Purpose

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 Intervention Phase
Esophageal Neoplasm
 Drug: UFT (Tegafur/Uracil)
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Edelman, Martin, M.D.:

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
University of Maryland Greenebaum Cancer Center Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00037089     History of Changes
Other Study ID Numbers: BMS-200604, UMCC 0110g
Study First Received: May 14, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013