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

Tracking Information
First Received Date ^ICMJE	May 14, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00037089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer
Official Title ^ICMJE
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Esophageal Neoplasm
Intervention ^ICMJE	Drug: UFT (Tegafur/Uracil)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 79 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00037089
Responsible Party
Study ID Numbers ^ICMJE	BMS-200604, UMCC 0110g
Study Sponsor ^ICMJE	Edelman, Martin, M.D.
Collaborators ^ICMJE	Bristol-Myers Squibb
Investigators ^ICMJE
Information Provided By	Edelman, Martin, M.D.
Verification Date	January 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP