T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00057382
• Other study ID #: T-067-010
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 31, 2003
• Last updated: June 23, 2005
• Start date: March 2003

Study information

• Verified date: September 2004
• Source: Tularik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00066287

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 750
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• T138067 intravenous

• doxorubicin intravenous

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tularik

Countries where clinical trial is conducted

United States,  Brazil,  China,  Poland,  Puerto Rico,  Russian Federation,  Singapore,  South Africa,  Thailand,  Ukraine,  United Kingdom,