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

Esophageal Neoplasm Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00037089
• Other study ID #: BMS-200604
• Secondary ID: UMCC 0110g
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 14, 2002
• Last updated: June 23, 2005

Study information

• Verified date: January 2005
• Source: Edelman, Martin, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

Drug:
• UFT (Tegafur/Uracil)

Locations

Country	Name	City	State
United States	University of Maryland Cancer Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Edelman, Martin, M.D.	Bristol-Myers Squibb

Country where clinical trial is conducted

United States,