A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Carcinoma, Hepatocellular

In brief

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).

Key facts

Study ID

NCT00108953

Run by

Bayer

People needed

96

Starts

2005-04-01

Expected to finish

2008-04-01

Last updated by the study team

2014-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Beverly Hills, California, United States
• Study site — Orange, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Francisco, California, United States
• Study site — San Francisco, California, United States
• Study site — Sylmar, California, United States
• Study site — Miami, Florida, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Nashville, Tennessee, United States
• Study site — Seattle, Washington, United States
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Neuquén, Neuquén Province, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Toronto, Ontario, Canada
• Study site — Hong Kong, Hong Kong, Hong Kong
• Study site — Kazan', Russia
• Study site — Kirov, Russia
• Study site — Krasnodar, Russia
• Study site — Maidstone, Kent, United Kingdom
• Study site — London, London, United Kingdom

Full record on ClinicalTrials.gov

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