Esophageal Cancer Clinical Trial

Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT00048529

Recruitment Status:

Suspended

Sponsor:

Tularik

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There are 5 Locations for this study

See Locations Near You

Pacific Oncology Associates
Los Gatos California, 95032, United States
Scripps Health Center
San Diego California, 92137, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico, 87131, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT00048529

Recruitment Status:

Suspended

Sponsor:


Tularik

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