Clinical trial NCT00057382: T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer
Lead sponsor: Tularik
Sponsor class: INDUSTRY
First posted: 2003-04-02
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.


Eligibility criteria: Key inclusion criteria include:

* pathologic diagnosis of unresectable HCC
* chemotherapy-naïve for HCC
* Child-Pugh Class A or B liver disease
* measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
* Karnofsky Performance Status of ≥ 70%
* life expectancy of ≥ 12 weeks
* adequate hematologic function (i.e., absolute neutrophil count \[ANC\] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
* total bilirubin of ≤ 1.5 upper limit of normal (ULN)
* aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
* serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

* severe, concurrent disease that would make the subject inappropriate for enrollment
* Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
* history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
* New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of \<50% or acute anginal symptoms
* females who are pregnant or breast-feeding
* received any investigational agent within 4 weeks of enrollment
* history of central nervous system metastases or carcinomatous meningitis
* clinically apparent ascites
* major surgery within 4 weeks of study enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Miami
country: United States
facility: VA Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Dallas
state: Texas
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz
city: Belo Horizonte
country: Brazil
facility: Hospital Mater Dei - Departamento de Oncologia
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-Sen Unversity
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Nanfang Hospital
state: Guangdong
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Nanjing
country: China
facility: Nanjing Ba Yi Hospital of PLA
state: Jiangsu
city: Xi AN
country: China
facility: 1st Affiliated Hospital of Xi An Jiao Tong University
state: Shanxi
city: Taipei
country: China
facility: Taipei Veteran General Hospital
state: Taiwan
city: Tao-Yuan
country: China
facility: Chang Gung Memorial Hospital
state: Taiwan
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Science (CAMS)
city: Beijing
country: China
facility: Beijing Cancer Hospital of Peking University
city: Beijing
country: China
facility: Gereral Hospital of PLA
city: Chongqing
country: China
facility: Chongqing Southwest Hospital
city: Hong Kong
country: China
facility: Prince Wales Hosptial
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
city: Shanghai
country: China
facility: Liver Cancer Institute, Zhongshan Hospital, Fudan University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: GdaDsk
country: Poland
facility: Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
city: Olsztyn
country: Poland
facility: Oddział Chemioterapii
city: Poznan
country: Poland
facility: Klinika Katedry Onkologii AM
city: San Juan
country: Puerto Rico
facility: San Juan Medical Center
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Redional Oncology Center, Department of Chemotherapy
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
facility: Cheliabinsk Regional Oncology Center
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Oncology Center
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Kazan
country: Russian Federation
facility: Kazan Republican Oncology Clinical Center
city: Krasnodar
country: Russian Federation
facility: Krasnodar City Oncology Center
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Center
city: Lipetsk
country: Russian Federation
facility: Lipetsk
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Ministry of Transport
city: Novosibirsk
country: Russian Federation
facility: Novosibirks Municipal Clinical Hospital #1
city: Obninsk
country: Russian Federation
facility: Russian Academy of Medical Sciences
city: Omsk 13
country: Russian Federation
facility: Omsk Regional Oncology Center
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Oncology Center
city: P/O Stepanovskoye
country: Russian Federation
facility: Moscow Oncology Hospital #62
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Research Oncology Institute
city: St Petersburg
country: Russian Federation
facility: Central Research Institute of Radiology of the Ministry of Health of Russian Federation
city: St Petersburg
country: Russian Federation
facility: Medical Academy of Postgraduate Education, St. Petersburg
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Mechnikov State Medical Academy
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Oncology Center
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Oncology Center
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Research Institute of Oncology
city: Ufa
country: Russian Federation
facility: Bashkiria Republican Oncology Center
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Oncology Center
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Oncology Center
city: Zhitomir
country: Russian Federation
facility: Zhitomir Regional Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Port Elizabeth
country: South Africa
facility: Eastern Cape Oncology Centre
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Muang Chiangmai
country: Thailand
facility: Chiangmai University
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk State Medical Academy
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Center
city: Kiev
country: Ukraine
facility: Kiev Central Military Clinical Hospital
city: Kiev
country: Ukraine
facility: Kiev Oncology Institute of Ukrainian Academy of Medical Science
city: Krivoy Rog
country: Ukraine
facility: Krivorojsky City Oncology Center
city: Lvov
country: Ukraine
facility: Lvov State Medical University
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Oncological Center
city: Vinnitsa
country: Ukraine
facility: Vinnitsa Regional Clinical Oncological Center
city: Zaporozhye
country: Ukraine
facility: Zaporozhje State Medical Institute of Postgraduate Education
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
affiliation: Tularik
name: Mohammad Hirmand, MD
role: STUDY_DIRECTOR
References: