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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 02, 2014