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Phase 2
18 Years
Not Enrolling
Gastric Cancer, Esophageal Neoplasms

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Trial Information

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of gastric cancer or
adenocarcinoma of the esophagus

- Subjects must have received 1-2 regimens of prior chemotherapy

- At least 18 years of age

- Bidimensionally measurable disease amenable to CT scanning. At least one lesion must
be least 1 X 1 cm in size.

- Karnofsky performance status of at least 70%

- Estimated life expectancy of at least 12 weeks

- Females of childbearing potential must have a negative pregnancy test and agree to
use an effective contraceptive

- Subject must be able to comply with study procedures and follow-up examinations.

- Signed written informed consent

- Lab Values (obtained ≤ 7 days prior to study enrollment):

- ANC at least 1.5x10e9/L, * Platelet count at least 100x10e9/L,

- Creatinine within 2 times upper limit of normal * AST and ALT within 5 times
upper limit of normal

- Bilirubin within 1.5 times upper limit of normal

- Albumin great than 2.5 g/dL

Exclusion Criteria

- Severe, concurrent disease, infection or co-morbidity that, in the judgment of the
investigator, would make the subject inappropriate for enrollment

- NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%,
or acute anginal symptoms

- Patients who have received any investigational agent within 4 weeks of enrollment

- Patients who are pregnant or breast-feeding

- History of prior malignancy other than gastric cancer or adenocarcinoma of the
esophagus within the last 5 years, except for adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- History of central nervous system metastases or carcinomatous meningitis

- Major surgery within 4 weeks of enrollment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kerrie Boyd

Investigator Role:

Study Chair


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Esophageal Neoplasms
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Ireland Cancer Center Cleveland, Ohio  44106-5065
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Scripps Health Center La Jolla, California  92037
Pacific Oncology Associates Los Gatos, California  95032
Moffitt Cancer Center Tampa, Florida  33612