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

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Hepatocellular	Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

Drug Information available for: Erlotinib hydrochloride Erlotinib Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Patient phone contacts after treatment is complete [ Time Frame: From the date of randomization until the date of death due to any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Progression, response rate, duration of response, disease control rate determined by tumor measurement using Magnetic Resonance Imaging (MRI) or CT scans [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
Health Related Quality of Life and Utility Values as measured by the EQ-5D [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
Laboratory testing [ Time Frame: Every 3 weeks during treatment ] [ Designated as safety issue: Yes ]
Adverse Event collection [ Time Frame: Every 3 weeks during treatment ] [ Designated as safety issue: Yes ]
Electrocardiogram [ Time Frame: At the start and at the completion of treatment ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Every 3 weeks during treatment ] [ Designated as safety issue: Yes ]

Enrollment:	732
Study Start Date:	May 2009
Estimated Study Completion Date:	July 2013
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Sorafenib (Nexavar, BAY43-9006) Sorafenib 400 mg twice daily + Matching Erlotinib Placebo daily
Active Comparator: Arm 2	Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva Sorafenib 400 mg twice daily + Erlotinib 150 mg daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901901

Show 163 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00901901 History of Changes
Other Study ID Numbers:	12917, 2008-006021-14
Study First Received:	May 13, 2009
Last Updated:	January 21, 2013
Health Authority:	United States: Food and Drug Administration Austrialia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency Canada: Health Canada Chile: Instituto de Salud Publica de Chile China: Food and Drug Administration Colombia: National Institutes of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: Ethics Committee Hong Kong: Department of Health Israel: Ethics Commission Italy: Ethics Committee Japan: Pharmaceuticals and Medical Devices Agency Peru: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Singapore: Health Sciences Authority South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Taiwan: Center for Drug Evaluation United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:

Sorafenib (Nexavar)
Erlotinib (Tarceva)
First Line
HCC

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

Liver Diseases
Erlotinib
Sorafenib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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