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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Edelman, Martin, M.D. Bristol-Myers Squibb
Information provided by:	Edelman, Martin, M.D.
ClinicalTrials.gov Identifier:	NCT00037089

Purpose

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.

Condition	Intervention	Phase
Esophageal Neoplasm	Drug: UFT (Tegafur/Uracil)	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Paclitaxel Tegafur Uracil

Study Type:	Interventional
Study Design:	Treatment

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

Contacts and Locations

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

Study ID Numbers:	BMS-200604, UMCC 0110g
Study First Received:	May 14, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00037089
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Tegafur
Paclitaxel
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Leucovorin
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009