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

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
T138067 intravenous
doxorubicin intravenous
Sponsored by
Tularik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • University of California at San Francisco
  • VA Medical Center
  • University of Miami
  • H. Lee Moffitt Cancer Center
  • Loyola University of Chicago
  • University of Pennsylvania
  • UT Southwestern Medical Center - Dallas
  • Hospital Vera Cruz
  • Hospital Mater Dei - Departamento de Oncologia
  • Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa
  • Hospital das Clínicas da Faculdade de Medicina da USP
  • Cancer Center, Sun Yat-Sen Unversity
  • Guangzhou Nanfang Hospital
  • Queen Mary Hospital
  • Nanjing Ba Yi Hospital of PLA
  • 1st Affiliated Hospital of Xi An Jiao Tong University
  • Taipei Veteran General Hospital
  • Chang Gung Memorial Hospital
  • Cancer Hospital of Chinese Academy of Medical Science (CAMS)
  • Beijing Cancer Hospital of Peking University
  • Gereral Hospital of PLA
  • Chongqing Southwest Hospital
  • Prince Wales Hosptial
  • The Affiliated Hospital of Medical College Qingdao University
  • Liver Cancer Institute, Zhongshan Hospital, Fudan University
  • Shanghai Changzheng Hospital
  • Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
  • Oddział Chemioterapii
  • Klinika Katedry Onkologii AM
  • San Juan Medical Center
  • Arkhangelsk Redional Oncology Center, Department of Chemotherapy
  • Cheliabinsk Regional Oncology Center
  • Irkutsk Regional Oncology Center
  • Kazan State Medical University
  • Kazan Republican Oncology Clinical Center
  • Krasnodar City Oncology Center
  • Krasnoyarsk Regional Oncology Center
  • Lipetsk
  • Blokhin Cancer Research Center
  • Central Clinical Hospital of the President of the Russian Federation
  • Central Clinical Hospital of the Ministry of Transport
  • Novosibirks Municipal Clinical Hospital #1
  • Russian Academy of Medical Sciences
  • Omsk Regional Oncology Center
  • Orenburg Regional Oncology Center
  • Moscow Oncology Hospital #62
  • Rostov Research Oncology Institute
  • Central Research Institute of Radiology of the Ministry of Health of Russian Federation
  • Medical Academy of Postgraduate Education, St. Petersburg
  • St. Petersburg Mechnikov State Medical Academy
  • St. Petersburg Oncology Center
  • Stavropol Regional Oncology Center
  • Tomsk Regional Research Institute of Oncology
  • Bashkiria Republican Oncology Center
  • Voronezh Regional Clinical Oncology Center
  • Yaroslavl Regional Oncology Center
  • Zhitomir Regional Hospital
  • National University Hospital
  • Eastern Cape Oncology Centre
  • Khon Kaen University
  • Chiangmai University
  • Dnepropetrovsk State Medical Academy
  • Donetsk Regional Antitumor Center
  • Kiev Central Military Clinical Hospital
  • Kiev Oncology Institute of Ukrainian Academy of Medical Science
  • Krivorojsky City Oncology Center
  • Lvov State Medical University
  • Poltava Regional Clinical Oncological Center
  • Vinnitsa Regional Clinical Oncological Center
  • Zaporozhje State Medical Institute of Postgraduate Education
  • Addenbrookes Hospital
  • Royal Free Hospital
  • Hammersmith Hospital
  • Christie Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 31, 2003
Last Updated
June 23, 2005
Sponsor
Tularik
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1. Study Identification

Unique Protocol Identification Number
NCT00057382
Brief Title
T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2004
Overall Recruitment Status
Terminated
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tularik

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
T138067 intravenous
Intervention Type
Drug
Intervention Name(s)
doxorubicin intravenous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Hirmand, MD
Organizational Affiliation
Tularik
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
VA Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Loyola University of Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UT Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9125
Country
United States
Facility Name
Hospital Vera Cruz
City
Belo Horizonte
ZIP/Postal Code
30190130
Country
Brazil
Facility Name
Hospital Mater Dei - Departamento de Oncologia
City
Belo Horizonte
ZIP/Postal Code
30190131
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa
City
Porto Alegre
ZIP/Postal Code
90020090
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
ZIP/Postal Code
5403000
Country
Brazil
Facility Name
Cancer Center, Sun Yat-Sen Unversity
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangzhou Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China
Facility Name
Nanjing Ba Yi Hospital of PLA
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
1st Affiliated Hospital of Xi An Jiao Tong University
City
Xi AN
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Taipei Veteran General Hospital
City
Taipei
State/Province
Taiwan
Country
China
Facility Name
Chang Gung Memorial Hospital
City
Tao-Yuan
State/Province
Taiwan
Country
China
Facility Name
Cancer Hospital of Chinese Academy of Medical Science (CAMS)
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital of Peking University
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Gereral Hospital of PLA
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Chongqing Southwest Hospital
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Prince Wales Hosptial
City
Hong Kong
Country
China
Facility Name
The Affiliated Hospital of Medical College Qingdao University
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Liver Cancer Institute, Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200070
Country
China
Facility Name
Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
City
GdaDsk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Oddział Chemioterapii
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Klinika Katedry Onkologii AM
City
Poznan
ZIP/Postal Code
61-878
Country
Poland
Facility Name
San Juan Medical Center
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Arkhangelsk Redional Oncology Center, Department of Chemotherapy
City
Arkhangelsk
ZIP/Postal Code
143045
Country
Russian Federation
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Cheliabinsk Regional Oncology Center
City
Chelyabinsk
ZIP/Postal Code
545087
Country
Russian Federation
Facility Name
Irkutsk Regional Oncology Center
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Kazan Republican Oncology Clinical Center
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Krasnodar City Oncology Center
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Oncology Center
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Lipetsk
City
Lipetsk
ZIP/Postal Code
398005
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Central Clinical Hospital of the President of the Russian Federation
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Central Clinical Hospital of the Ministry of Transport
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Novosibirks Municipal Clinical Hospital #1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences
City
Obninsk
ZIP/Postal Code
249020
Country
Russian Federation
Facility Name
Omsk Regional Oncology Center
City
Omsk 13
Country
Russian Federation
Facility Name
Orenburg Regional Oncology Center
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Moscow Oncology Hospital #62
City
P/O Stepanovskoye
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Rostov Research Oncology Institute
City
Rostov-on-Don
ZIP/Postal Code
344713
Country
Russian Federation
Facility Name
Central Research Institute of Radiology of the Ministry of Health of Russian Federation
City
St Petersburg
ZIP/Postal Code
189646
Country
Russian Federation
Facility Name
Medical Academy of Postgraduate Education, St. Petersburg
City
St Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
St. Petersburg Mechnikov State Medical Academy
City
St Petersburg
ZIP/Postal Code
195065
Country
Russian Federation
Facility Name
St. Petersburg Oncology Center
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Stavropol Regional Oncology Center
City
Stavropol
ZIP/Postal Code
355018
Country
Russian Federation
Facility Name
Tomsk Regional Research Institute of Oncology
City
Tomsk
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Bashkiria Republican Oncology Center
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Oncology Center
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Yaroslavl Regional Oncology Center
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Zhitomir Regional Hospital
City
Zhitomir
ZIP/Postal Code
10002
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Eastern Cape Oncology Centre
City
Port Elizabeth
Country
South Africa
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Chiangmai University
City
Muang Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Dnepropetrovsk State Medical Academy
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Center
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Kiev Central Military Clinical Hospital
City
Kiev
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
Kiev Oncology Institute of Ukrainian Academy of Medical Science
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Krivorojsky City Oncology Center
City
Krivoy Rog
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Lvov State Medical University
City
Lvov
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Poltava Regional Clinical Oncological Center
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Oncological Center
City
Vinnitsa
ZIP/Postal Code
21021
Country
Ukraine
Facility Name
Zaporozhje State Medical Institute of Postgraduate Education
City
Zaporozhye
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 OH5
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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