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

Edelman, Martin, M.D.

Status and phase: Unknown; Phase 2

Conditions: Esophageal Neoplasm

Treatments: Drug: UFT (Tegafur/Uracil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037089

BMS-200604

UMCC 0110g

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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