T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
1 other identifier
interventional
750
11 countries
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 31, 2003
CompletedFirst Posted
Study publicly available on registry
April 2, 2003
CompletedJune 24, 2005
September 1, 2004
March 31, 2003
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- pathologic diagnosis of unresectable HCC
- chemotherapy-naĂ¯ve 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tulariklead
Study Sites (76)
University of Alabama
Birmingham, Alabama, 35294, United States
University of California at San Francisco
San Francisco, California, 94115, United States
VA Medical Center
Miami, Florida, 33125, United States
University of Miami
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Loyola University of Chicago
Maywood, Illinois, 60153, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UT Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9125, United States
Hospital Vera Cruz
Belo Horizonte, 30190130, Brazil
Hospital Mater Dei - Departamento de Oncologia
Belo Horizonte, 30190131, Brazil
Irmandade Santa Casa de MisericĂ³rdia de Porto Alegre - Unidade de Apoio Ă Pesquisa
Porto Alegre, 90020090, Brazil
Hospital das ClĂnicas da Faculdade de Medicina da USP
SĂ£o Paulo, 5403000, Brazil
Cancer Center, Sun Yat-Sen Unversity
Guangzhou, Guangdong, 510060, China
Guangzhou Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Queen Mary Hospital
Hong Kong, Hong Kong, China
Nanjing Ba Yi Hospital of PLA
Nanjing, Jiangsu, 210002, China
1st Affiliated Hospital of Xi An Jiao Tong University
Xi’an, Shanxi, 710061, China
Taipei Veteran General Hospital
Taipei, Taiwan, China
Chang Gung Memorial Hospital
Taoyuan, Taiwan, China
Cancer Hospital of Chinese Academy of Medical Science (CAMS)
Beijing, 100021, China
Beijing Cancer Hospital of Peking University
Beijing, 100036, China
Gereral Hospital of PLA
Beijing, 100853, China
Chongqing Southwest Hospital
Chongqing, 400038, China
Prince Wales Hosptial
Hong Kong, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003, China
Liver Cancer Institute, Zhongshan Hospital, Fudan University
Shanghai, 200032, China
Shanghai Changzheng Hospital
Shanghai, 200070, China
Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
GdaDsk, 80-211, Poland
Oddział Chemioterapii
Olsztyn, 10-228, Poland
Klinika Katedry Onkologii AM
Poznan, 61-878, Poland
San Juan Medical Center
San Juan, 00927, Puerto Rico
Arkhangelsk Redional Oncology Center, Department of Chemotherapy
Arkhangelsk, 143045, Russia
Unknown Facility
Barnaul, 656049, Russia
Cheliabinsk Regional Oncology Center
Chelyabinsk, 545087, Russia
Irkutsk Regional Oncology Center
Irkutsk, 664035, Russia
Kazan State Medical University
Kazan', 420012, Russia
Kazan Republican Oncology Clinical Center
Kazan', 420029, Russia
Krasnodar City Oncology Center
Krasnodar, 350040, Russia
Krasnoyarsk Regional Oncology Center
Krasnoyarsk, 660133, Russia
Lipetsk
Lipetsk, 398005, Russia
Blokhin Cancer Research Center
Moscow, 115478, Russia
Central Clinical Hospital of the President of the Russian Federation
Moscow, 121356, Russia
Central Clinical Hospital of the Ministry of Transport
Moscow, 129128, Russia
Novosibirks Municipal Clinical Hospital #1
Novosibirsk, 630047, Russia
Russian Academy of Medical Sciences
Obninsk, 249020, Russia
Omsk Regional Oncology Center
Omsk, Russia
Orenburg Regional Oncology Center
Orenburg, 460021, Russia
Moscow Oncology Hospital #62
P/O Stepanovskoye, 143423, Russia
Rostov Research Oncology Institute
Rostov-on-Don, 344713, Russia
Central Research Institute of Radiology of the Ministry of Health of Russian Federation
Saint Petersburg, 189646, Russia
Medical Academy of Postgraduate Education, St. Petersburg
Saint Petersburg, 193015, Russia
St. Petersburg Mechnikov State Medical Academy
Saint Petersburg, 195065, Russia
St. Petersburg Oncology Center
Saint Petersburg, 197022, Russia
Stavropol Regional Oncology Center
Stavropol, 355018, Russia
Tomsk Regional Research Institute of Oncology
Tomsk, 634028, Russia
Bashkiria Republican Oncology Center
Ufa, 450054, Russia
Voronezh Regional Clinical Oncology Center
Voronezh, 394000, Russia
Yaroslavl Regional Oncology Center
Yaroslavl, 150054, Russia
Zhitomir Regional Hospital
Zhitomir, 10002, Russia
National University Hospital
Singapore, 119074, Singapore
Eastern Cape Oncology Centre
Port Elizabeth, South Africa
Khon Kaen University
Khon Kaen, 40002, Thailand
Chiangmai University
Muang Chiangmai, 50200, Thailand
Dnepropetrovsk State Medical Academy
Dnipro, 49102, Ukraine
Donetsk Regional Antitumor Center
Donetsk, 83092, Ukraine
Kiev Central Military Clinical Hospital
Kiev, 01133, Ukraine
Kiev Oncology Institute of Ukrainian Academy of Medical Science
Kiev, 03022, Ukraine
Krivorojsky City Oncology Center
Kryvyi Rih, 50048, Ukraine
Lvov State Medical University
Lviv, 79031, Ukraine
Poltava Regional Clinical Oncological Center
Poltava, 36011, Ukraine
Vinnitsa Regional Clinical Oncological Center
Vinnitsa, 21021, Ukraine
Zaporozhje State Medical Institute of Postgraduate Education
Zaporizhzhya, 69104, Ukraine
Addenbrookes Hospital
Cambridge, CB2 2QQ, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Hammersmith Hospital
London, W12 OH5, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammad Hirmand, MD
Tularik
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 31, 2003
First Posted
April 2, 2003
Study Start
March 1, 2003
Last Updated
June 24, 2005
Record last verified: 2004-09