Esophageal Neoplasms, Gastric Cancer
Conditions
Keywords
adenocarcinoma of the esophagus
Brief summary
This is a clinical research study of T900607-sodium to determine if it is effective and safe in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a weekly basis with an intravenous injection of the study drug.
Interventions
DRUGT900607-sodium intravenous
Sponsors
Tularik
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed