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



Status:Completed
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/8/2018
Start Date:May 21, 2009
End Date:May 23, 2018

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A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

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.

European quality of life scale (5 dimensions) (EQ-5D)

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)
We found this trial at
23
sites
964
mi
from 91732
Seattle, WA
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1919
mi
from 91732
Atlanta, GA
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2301
mi
from 91732
Baltimore, MD
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2578
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from 91732
Boston, MA
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Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
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1966
mi
from 91732
Detroit, MI
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2103
mi
from 91732
Gainesville, FL
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2573
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from 91732
Honolulu, HI
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1357
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from 91732
Houston, TX
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1813
mi
from 91732
Louisville, KY
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1718
mi
from 91732
Maywood, IL
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2321
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from 91732
Miami, FL
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1511
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from 91732
Minneapolis, MN
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1655
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from 91732
New Orleans, LA
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2435
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from 91732
New York, NY
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2375
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from 91732
Philadelphia, PA
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7513
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from 91732
Randwick,
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2245
mi
from 91732
Rochester, NY
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355
mi
from 91732
San Francisco, CA
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2443
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from 91732
Valhalla, NY
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2281
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from 91732
Washington,
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1338
mi
from 91732
Westwood, KS
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2540
mi
from 91732
Worcester, MA
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