Gastric Cancer Clinical Trial
NCT number | NCT00048529 |
Other study ID # | T-607-006 |
Secondary ID | |
Status | Suspended |
Phase | Phase 2 |
First received | November 1, 2002 |
Last updated | June 23, 2005 |
Start date | September 2002 |
Verified date | April 2004 |
Source | Tularik |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 70 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Pacific Oncology Associates | Los Gatos | California |
United States | Scripps Health Center | San Diego | California |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Tularik |
United States,
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