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

Paused · Phase 2

Conditions studied: Gastric Cancer, Esophageal Neoplasms

In brief

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.

Key facts

Study ID

NCT00048529

Run by

Tularik

People needed

70

Starts

2002-09-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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