Trial record 1 of 1 for:    NCT00901901
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Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma (SEARCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00901901
First received: May 13, 2009
Last updated: July 9, 2014
Last verified: July 2014
  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:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization of the first patient until 34 months or date of death of any cause whichever came first ] [ Designated as safety issue: No ]
    Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.


Secondary Outcome Measures:
  • Time to Radiological Tumor Progression (TTP) [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ] [ Designated as safety issue: No ]
    TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.

  • Disease Control [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ] [ Designated as safety issue: No ]
    Disease control was defined as the number of participants who had a best response rating of complet response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.

  • Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index [ Time Frame: The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. ] [ Designated as safety issue: No ]
    The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.

  • Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS [ Time Frame: The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. ] [ Designated as safety issue: No ]
    Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.


Other Outcome Measures:
  • Duration of Response [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ] [ Designated as safety issue: No ]
    Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.

  • Time to Response [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ] [ Designated as safety issue: No ]
    Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).

  • Tumor Response [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ] [ Designated as safety issue: No ]
    Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).


Enrollment: 732
Study Start Date: May 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)
Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily + matching erlotinib placebo daily
Active Comparator: Sorafenib (Nexavar, BAY43-9006) + Placebo
Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva
Sorafenib 400 mg twice daily + erlotinib 150 mg daily

Detailed Description:

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

  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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92037
San Francisco, California, United States, 94115
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Gainesville, Florida, United States, 32610
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30318
United States, Hawaii
Honolulu, Hawaii, United States, 96817
United States, Illinois
Maywood, Illinois, United States, 60153-5585
United States, Kansas
Westwood, Kansas, United States, 66205
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
Shreveport, Louisiana, United States, 71103
United States, Maryland
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Boston, Massachusetts, United States, 02215-5450
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
Worcester, Massachusetts, United States, 01655
United States, Michigan
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Buffalo, New York, United States, 14263
New York, New York, United States, 10029
Rochester, New York, United States, 14642
Valhalla, New York, United States, 10595
United States, North Carolina
Charlotte, North Carolina, United States, 28203
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Philadelpahia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Seattle, Washington, United States, 98109-1023
Australia, New South Wales
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Brisbane, Queensland, Australia, 4120
Herston, Queensland, Australia, 4029
Australia, Victoria
Clayton, Victoria, Australia, 3168
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Austria
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1200
Edegem, Belgium, 2650
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
La Louviere, Belgium, 7100
Leuven, Belgium, 3000
Liege, Belgium, 4000
Brazil
Belo Horizonte, Minas Gerais, Brazil, 30110-090
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
São Paulo, Sao Paulo, Brazil, 05651-900
Rio de Janeiro, Brazil, 21941-913
Sao Paulo, Brazil, 01509-900
Sao Paulo, Brazil, 05403-000
Bulgaria
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1784
Varna, Bulgaria, 9010
Varna, Bulgaria, 9002
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Chile
Temuco, Araucanía, Chile
Viña del Mar, V Region, Chile
Santiago, Chile, 7601003
Santiago, Chile, 838-0455
China, Guangdong
Guangzhou, Guangdong, China, 510060
China, Jiangsu
Nanjing, Jiangsu, China, 210002
China, Zhejiang
Hangzhou, Zhejiang, China, 310016
China
Beijing, China, 100021
Beijing, China, 100071
Colombia
Bogotá, Colombia
Bucaramanga, Colombia
Cali, Colombia
Floridablanca, Colombia
Medellín, Colombia
France
Bordeaux, France, 33000
Clichy, France, 92110
Creteil, France, 94010
La Roche Sur Yon, France, 85925
Lille, France, 59037
Lyon Cedex 04, France, 69317
Marseille, France, 13005
Paris, France, 75012
Pessac, France, 33604
Vandoeuvre-les-nancy, France, 54500
Villejuif, France, 94800
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg, Baden-Württemberg, Germany, 69120
Tübingen, Baden-Württemberg, Germany, 72076
München, Bayern, Germany, 81675
Regensburg, Bayern, Germany, 93042
Frankfurt, Hessen, Germany, 60590
Hannover, Niedersachsen, Germany, 30625
Essen, Nordrhein-Westfalen, Germany, 45147
Köln, Nordrhein-Westfalen, Germany, 50937
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg, Saarland, Germany, 66421
Dresden, Sachsen, Germany, 01127
Berlin, Germany, 12200
Greece
Athens, Attica, Greece, 11527
Athens, Greece, 11528
Athens, Greece, 115 27
Heraklion, Greece, 711 10
Larissa, Greece, 41111
Thessaloniki, Greece, 54642
Thessaloniki, Greece, 546 36
Hong Kong
Shatin, New Territories, Hong Kong
Hong Kong, Hong Kong
Israel
Beer Sheva, Israel, 8410101
Haifa, Israel, 3109601
Petach Tikva, Israel, 4941492
Rehovot, Israel, 7610001
Tel Hashomer, Israel, 5262000
Zrifin, Israel, 6093000
Italy
Rozzano, Milano, Italy, 20089
Bergamo, Italy, 24128
Reggio Emilia, Italy, 42100
Korea, Republic of
Goyang-si, Gyeonggido, Korea, Republic of, 410-769
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of, 138-736
New Zealand
Auckland, New Zealand, 1023
Christchurch, New Zealand, 8011
Wellington South, New Zealand, 6021
Peru
Lima, Peru, LIMA 1
Lima, Peru, 01
Lima, Peru, LIMA 34
Lima, Peru, LIMA 27
Lima Cercado, Peru, LIMA 1
Poland
Bydgoszcz, Poland, 85-796
Gdansk, Poland, 80-952
Gliwice, Poland, 44-101
Warszawa, Poland, 02-781
Russian Federation
Barnaul, Russian Federation, 656049
Kazan, Russian Federation, 420029
Kemerovo, Russian Federation, 650 099
Moscow, Russian Federation, 115478
Nizhny Novgorod, Russian Federation, 603001
St.Petersburg, Russian Federation
Yaroslavl, Russian Federation, 150054
Singapore
Singapore, Singapore, 308433
Singapore, Singapore, 169610
South Africa
Port Elizabeth, Eastern Cape, South Africa, 6045
Johannesburg, Gauteng, South Africa, 2132
Durban, Kwazulu-Natal, South Africa, 2091
Cape Town, Western Cape, South Africa, 7500
Spain
Hospitalet de Llobregat, Barcelona, Spain, 08907
San Sebastián de los Reyes, Madrid, Spain, 28702
Barcelona, Spain, 08036
Lugo, Spain, 27003
Madrid, Spain, 28041
Madrid, Spain, 28040
Málaga, Spain, 29010
Santander, Spain, 39008
Valencia, Spain, 46010
Valencia, Spain, 46026
Taiwan
Tainan, Taiwan, 736
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
United Kingdom
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Glasgow, United Kingdom, G12 0YN
London, United Kingdom, SE5 9RS
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00901901     History of Changes
Other Study ID Numbers: 12917, 2008-006021-14
Study First Received: May 13, 2009
Results First Received: April 10, 2013
Last Updated: July 9, 2014
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 Pública 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, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Erlotinib
Niacinamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014