Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
NCT ID: NCT00043433
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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intravenous T900607-sodium
Eligibility Criteria
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Inclusion Criteria
* Child-Pugh liver classification of A or B
* Subjects must not have received prior chemotherapy or radiotherapy for their HCC
* 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 2.8 g/dL
Exclusion Criteria
* 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 cancer studied 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
* Patients who have received prior chemotherapy, chemoembolization, immunotherapy, or radiotherapy for their HCC. Prior surgical resection, intratumoral ethanol injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal radiation or embolization, is permitted ONLY if \> 6 weeks has passed since therapy and there is an indicator lesion (\> 1 x 1 cm) outside the area of prior treatment (recurrence at the margin or resection is allowed)
18 Years
ALL
No
Sponsors
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Tularik
INDUSTRY
Principal Investigators
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Charlene Sum
Role: STUDY_CHAIR
Tularik
Locations
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Scripps Health Center
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
George Washington University
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
Ireland Cancer Center
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Queen Mary Hospital
Hong Kong, , China
Countries
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Other Identifiers
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T-607-004
Identifier Type: -
Identifier Source: org_study_id