This trial is active, not recruiting.

Condition esophageal neoplasm
Treatment uft (tegafur/uracil)
Phase phase 2
Sponsor Edelman, Martin, M.D.
Collaborator Bristol-Myers Squibb
Trial identifier NCT00037089, BMS-200604, UMCC 0110g


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Edelman, Martin, M.D..