Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Hepatocellular

In brief

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Key facts

Study ID

NCT00901901

Run by

Bayer

People needed

732

Starts

2009-05-21

Expected to finish

2018-05-23

Last updated by the study team

2019-05-30

Who can join

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

You may qualify if…

• Patients > 18 years of age
• Patients who have a life expectancy of at least 12 weeks
• Patients with histological or cytologically documented HCC
• Patients must have at least one tumor lesion that meets both of the following criteria:
• The lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (RECIST)
• The lesion has not been previously treated with local therapy
• Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
• Cirrhotic status of Child-Pugh class A.
• Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time.

You may not qualify if…

• History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
• Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren's syndrome) including congenital abnormality (e.g. Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
• History of interstitial lung disease (ILD).
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Previous treatment with yttrium-90 spheres
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
• Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Maywood, Illinois, United States
• Study site — Westwood, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Randwick, New South Wales, Australia
• Study site — Brisbane, Queensland, Australia
• Study site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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