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Phase 2
18 Years
79 Years
Open (Enrolling)
Both
Esophageal Neoplasm

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Trial Information

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

BMS-200604

NCT ID:

NCT00037089

Start Date:

Completion Date:

Related Keywords:

  • Esophageal Neoplasm
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of Maryland Cancer Center Baltimore, Maryland  21201