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Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. Clinical research trials and Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.. Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. clinical trial. Participants frequently obtain the most expert healthcare available for their Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma. condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.  Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.
Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.
For Condition: Hepatocellular Carcinoma
Status: No longer recruiting
Sponsor(s): Tularik ,
Synopsis: The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.
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 HCC - 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 - 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 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)
Total Enrollment: 35
Location and Contact Information:
Overall Study Official:
CharleneSum, Study Chair, Tularik
University of California San Diego
La Jolla, California, 92093
United States
Queen Mary Hospital
Hong Kong, ,
China
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
George Washington University
Washington D.C., District of Columbia, 20037
United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Scripps Health Center
La Jolla, California, 92037
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
University of Rochester
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: T-607-004;
Study Start Date: July 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043433
Other Hepatocellular Carcinoma Studies:
1. Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.
2. Safety and Tolerability of I.V. Infusion of MB07133 in Patients with Unresectable Hepatocellular Carcinoma
3. T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients
4. Prevention of Recurrent Hepatitis B after Liver Transplantation
5. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads
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Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.
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