Clinical trial NCT00043433: Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Lead sponsor: Tularik
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Tularik
name: Charlene Sum
role: STUDY_CHAIR
References: