Trial Condition(s):

Carcinoma, Hepatocellular

A Research Study to Treat Patients with Advanced Hepatocellular Carcinoma

Bayer Identifier:

11546

ClinicalTrials.gov Identifier:

NCT00108953

EudraCT Number:

2004-001770-40

Study Completed

Trial Purpose

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Inclusion Criteria
- Patients who have a life expectancy of at least 12 weeks
 - Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
 - Patients must have at least one tumor lesion that meets both of the following criteria:
 -- can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
 -- has not been previously treated with local therapy
 - Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
 - Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1).  Any cancer curatively treated > 3 years prior to entry is permitted
 - History of cardiac disease
 - Serious myocardial dysfunction
 - Active, clinically serious infections
 - Known history of Human Immunodeficiency Virus (HIV) infection
 - Known Central Nervous System (CNS) tumors including metastatic brain disease
 - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Trial Summary

Enrollment Goal
96
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Clatterbridge Centre for Oncology

Bebington, United Kingdom, CH63 4JY

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Kent Oncology Centre

Maidstone, United Kingdom, ME16 9QQ

Status
Completed
 
Locations

VA Palo Alto Health Care System

Palo Alto, United States, 94304-1207

Status
Completed
 
Locations

California Pacific Medical Center

San Francisco, United States, 94115

Status
Completed
 
Locations

Hackensack University Medical Center

Hackensack, United States, 07601

Status
Completed
 
Locations

University of Rochester Medical Center

Rochester, United States, 14642

Status
Completed
 
Locations

Veterans Affairs Medical Center-San Francisco

San Francisco, United States, 94121

Status
Completed
 
Locations

Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Unidad Oncológica de Neuquén

Neuquen, Argentina, Q8300HDH

Status
Completed
 
Locations

Hosp. Mun. de Gastroenterología Dr. Carlos Bonorino Udaondo

Buenos Aires, Argentina, C1264AAA

Status
Completed
 
Locations

Oncology Centre of Kazan State Medical University

Kazan, Russia, 420111

Status
Completed
 
Locations

Krasnodar City Oncology Center

Krasnodar, Russia, 350040

Status
Completed
 
Locations

Kirov State Medical Academy

Kirov, Russia, 610002

Status
Completed
 
Locations

University of Birmingham

Birmingham, United Kingdom, B15 2TT

Status
Completed
 
Locations

Hammersmith Hospital

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Memorial Sloan-Kettering Cancer Center

New York, United States, 10065

Status
Completed
 
Locations

University of Miami School of Medicine

Miami, United States, 33136

Status
Completed
 
Locations

University of Minnesota

Minneapolis, United States, 55455

Status
Completed
 
Locations

Sarah Cannon Cancer Center

Nashville, United States, 37203

Status
Completed
 
Locations

Tower Hematology/Oncology Medical Group

Beverly Hills, United States, 90211-1850

Status
Completed
 
Locations

Virginia Mason Medical Center

Seattle, United States, 98101

Status
Completed
 
Locations

UCLA Medical Center-Olive View

Sylmar, United States, 91342

Status
Completed
 
Locations

UC Irvine Medical Center

Orange, United States, 92668-3298

Status
Completed
 
Locations

Louisiana Oncology Associates, PMC

Lafayette, United States, 70506

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35294

Status
Completed
 
Locations

Hospital Británico

Buenos Aires, Argentina

Status
Completed
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 

Trial Design