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Study of T900607-sodium in subjects with previously treated gastric cancer or adenocarcinoma of the esophagus



Study of T900607-sodium in subjects with previously treated gastric cancer or adenocarcinoma of the esophagus

For Condition: Gastric Cancer,Esophageal Neoplasms
Status: Suspended
Sponsor(s): Tularik ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 70

Location and Contact Information:

Overall Study Official:
KerrieBoyd,  Study Chair, 

Pacific Oncology Associates
Los Gatos,  California,  95032
United States
 

Moffitt Cancer Center
Tampa,  Florida,  33612
United States
 

Scripps Health Center
San Diego,  California,  92137
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106
United States
 

University of New Mexico Cancer Research and Treatment Center
Albuquerque,  New Mexico,  87131
United States
 


Additional Information:
Study ID Numbers:
  T-607-006; 
Study Start Date: September 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048529

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