Esophageal Cancer Clinical Trial
A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer
Summary
This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to:
Determine how well a combination of taxol, UFT, and leucovorin work in these patients,
Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs.
Identify the side effects of this drug combination.
Eligibility 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
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There is 1 Location for this study
Baltimore Maryland, 21201, United States
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