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



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

For Condition: Esophageal Neoplasm
Status: Recruiting
Sponsor(s): Edelman, Martin, M.D. , Bristol-Myers Squibb
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/79 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

University of Maryland Cancer Center *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Ruth  Smith 410-328-9166


Additional Information:
Study ID Numbers:
  BMS-200604;  UMCC 0110g
Study Start Date: 
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037089

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3. A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients with Metastatic Esophageal Cancer

4. Familial Aggregation of Barrett's Esophagus

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