The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

Condition	Treatment or Intervention	Phase
Hepatocellular Carcinoma	Drug: intravenous T900607-sodium	Phase II

Further Study Details: 

Expected Total Enrollment:  35

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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)

California
      Scripps Health Center, La Jolla,  California,  92037,  United States
      University of California San Diego, La Jolla,  California,  92093,  United States
District of Columbia
      George Washington University, Washington,  District of Columbia,  20037,  United States
Florida
      H. Lee Moffitt Cancer Center, Tampa,  Florida,  33612,  United States
Missouri
      Ellis Fischel Cancer Center, Columbia,  Missouri,  65203,  United States
New Mexico
      University of New Mexico, Albuquerque,  New Mexico,  87131,  United States
New York
      University of Rochester, Rochester,  New York,  14642,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
Texas
      University of Texas Southwestern Medical Center, Dallas,  Texas,  75390,  United States
China
      Queen Mary Hospital, Hong Kong,  China

Study chairs or principal investigators

Charlene Sum,  Study Chair,  Tularik   

Study ID Numbers:  T-607-004
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  August 8, 2002
ClinicalTrials.gov Identifier:  NCT00043433
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08