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Phase 2
18 Years
N/A
Not Enrolling
Both
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:

Interventional

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

Authority:

United States: Food and Drug Administration

Study ID:

T-607-006

NCT ID:

NCT00048529

Start Date:

September 2002

Completion Date:

Related Keywords:

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

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Scripps Health CenterLa Jolla, California  92037
Pacific Oncology AssociatesLos Gatos, California  95032
Moffitt Cancer CenterTampa, Florida  33612