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

June 23, 2005 updated by: Tularik
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

750

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil, 30190130
        • Hospital Vera Cruz
      • Belo Horizonte, Brazil, 30190131
        • Hospital Mater Dei - Departamento de Oncologia
      • Porto Alegre, Brazil, 90020090
        • Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa
      • São Paulo, Brazil, 5403000
        • Hospital das Clínicas da Faculdade de Medicina da USP
  • China
      • Beijing, China, 100021
        • Cancer Hospital of Chinese Academy of Medical Science (CAMS)
      • Beijing, China, 100036
        • Beijing Cancer Hospital of Peking University
      • Beijing, China, 100853
        • Gereral Hospital of PLA
      • Chongqing, China, 400038
        • Chongqing Southwest Hospital
      • Hong Kong, China
        • Prince Wales Hosptial
      • Qingdao, China, 266003
        • The Affiliated Hospital of Medical College Qingdao University
      • Shanghai, China, 200032
        • Liver cancer institute, Zhongshan Hospital, Fudan University
      • Shanghai, China, 200070
        • Shanghai Changzheng Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center, Sun Yat-Sen Unversity
      • Guangzhou, Guangdong, China, 510515
        • Guangzhou Nanfang Hospital
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Queen Mary Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Nanjing Ba Yi Hospital of PLA
    • Shanxi
      • Xi AN, Shanxi, China, 710061
        • 1st Affiliated Hospital of Xi An Jiao Tong University
    • Taiwan
      • Taipei, Taiwan, China
        • Taipei Veteran General Hospital
      • Tao-Yuan, Taiwan, China
        • Chang Gung Memorial Hospital
  • Poland
      • GdaDsk, Poland, 80-211
        • Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
      • Olsztyn, Poland, 10-228
        • Oddział Chemioterapii
      • Poznan, Poland, 61-878
        • Klinika Katedry Onkologii AM
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • San Juan Medical Center
  • Russian Federation
      • Arkhangelsk, Russian Federation, 143045
        • Arkhangelsk Redional Oncology Center, Department of Chemotherapy
      • Barnaul, Russian Federation, 656049
      • Chelyabinsk, Russian Federation, 545087
        • Cheliabinsk Regional Oncology Center
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Oncology Center
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Kazan, Russian Federation, 420029
        • Kazan Republican Oncology Clinical Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar City Oncology Center
      • Krasnoyarsk, Russian Federation, 660133
        • Krasnoyarsk Regional Oncology Center
      • Lipetsk, Russian Federation, 398005
        • Lipetsk
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center
      • Moscow, Russian Federation, 121356
        • Central Clinical Hospital of the President of the Russian Federation
      • Moscow, Russian Federation, 129128
        • Central Clinical Hospital of the Ministry of Transport
      • Novosibirsk, Russian Federation, 630047
        • Novosibirks Municipal Clinical Hospital #1
      • Obninsk, Russian Federation, 249020
        • Russian Academy of Medical Sciences
      • Omsk 13, Russian Federation
        • Omsk Regional Oncology Center
      • Orenburg, Russian Federation, 460021
        • Orenburg Regional Oncology Center
      • P/O Stepanovskoye, Russian Federation, 143423
        • Moscow Oncology Hospital #62
      • Rostov-on-Don, Russian Federation, 344713
        • Rostov Research Oncology Institute
      • St Petersburg, Russian Federation, 189646
        • Central Research Institute of Radiology of the Ministry of Health of Russian Federation
      • St Petersburg, Russian Federation, 193015
        • Medical Academy of Postgraduate Education, St. Petersburg
      • St Petersburg, Russian Federation, 195065
        • St. Petersburg Mechnikov State Medical Academy
      • St Petersburg, Russian Federation, 197022
        • St. Petersburg Oncology Center
      • Stavropol, Russian Federation, 355018
        • Stavropol Regional Oncology Center
      • Tomsk, Russian Federation, 634028
        • Tomsk Regional Research Institute of Oncology
      • Ufa, Russian Federation, 450054
        • Bashkiria Republican Oncology Center
      • Voronezh, Russian Federation, 394000
        • Voronezh Regional Clinical Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Oncology Center
      • Zhitomir, Russian Federation, 10002
        • Zhitomir Regional Hospital
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
  • South Africa
      • Port Elizabeth, South Africa
        • Eastern Cape Oncology Centre
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University
      • Muang Chiangmai, Thailand, 50200
        • Chiangmai University
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49102
        • Dnepropetrovsk State Medical Academy
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antitumor Center
      • Kiev, Ukraine, 01133
        • Kiev Central Military Clinical Hospital
      • Kiev, Ukraine, 03022
        • Kiev Oncology Institute of Ukrainian Academy of Medical Science
      • Krivoy Rog, Ukraine, 50048
        • Krivorojsky City Oncology Center
      • Lvov, Ukraine, 79031
        • Lvov State Medical University
      • Poltava, Ukraine, 36011
        • Poltava Regional Clinical Oncological Center
      • Vinnitsa, Ukraine, 21021
        • Vinnitsa Regional Clinical Oncological Center
      • Zaporozhye, Ukraine, 69104
        • Zaporozhje State Medical Institute of Postgraduate Education
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrookes Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, W12 OH5
        • Hammersmith Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • San Francisco, California, United States, 94115
        • University of California at San Francisco
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33125
        • Va Medical Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University of Chicago
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390-9125
        • UT Southwestern Medical Center - Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tularik

Investigators

  • Study Director: Mohammad Hirmand, MD, Tularik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Registration Dates

First Submitted

March 31, 2003

First Submitted That Met QC Criteria

April 1, 2003

First Posted (Estimate)

April 2, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

September 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-067-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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