check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

12917

ClinicalTrials.gov Identifier:

NCT00901901

EudraCT Number:

2008-006021-14

EU CT Number:

Not Available
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular carcinoma

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.
  • - 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)

Trial summary

Enrollment Goal
732
Trial Dates
May 2009 - May 2018
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Freiburg, 79106, Germany
Completed
München, 81675, Germany
Completed
Hannover, 30625, Germany
Completed
Homburg, 66421, Germany
Completed
Regensburg, 93042, Germany
Withdrawn
Dresden, 01127, Germany
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
San Francisco, 94115, United States
Completed
Miami, 33136, United States
Withdrawn
Buffalo, 14263, United States
Completed
Honolulu, 96817, United States
Completed
Boston, 02215-5450, United States
Completed
Westwood, 66205, United States
Completed
Mainz, 55131, Germany
Completed
Tübingen, 72076, Germany
Completed
Berlin, 12200, Germany
Completed
Frankfurt, 60590, Germany
Completed
Essen, 45147, Germany
Completed
Köln, 50937, Germany
Completed
London, SE5 9RS, United Kingdom
Completed
Sheffield, S10 2SJ, United Kingdom
Completed
Glasgow, G12 0YN, United Kingdom
Completed
New York, 10029, United States
Completed
Baltimore, 21202, United States
Completed
Philadelpahia, 19107, United States
Completed
Atlanta, 30318, United States
Completed
Detroit, 48202, United States
Withdrawn
St. Louis, 63110, United States
Withdrawn
La Jolla, 92037, United States
Completed
New Orleans, 70112, United States
Completed
Louisville, 40202, United States
Completed
PARIS, 75012, France
Completed
VILLEJUIF, 94800, France
Completed
BORDEAUX, 33000, France
Completed
LA ROCHE SUR YON, 85925, France
Completed
Gliwice, 44-101, Poland
Completed
Milano, 20089, Italy
Withdrawn
Madrid, 28041, Spain
Completed
Valencia, 46026, Spain
Completed
Seattle, 98109-1023, United States
Completed
Gainesville, 32610, United States
Completed
Boston, 02114, United States
Withdrawn
Boston, 02215, United States
Withdrawn
Albuquerque, 87106, United States
Completed
Washington, 20007, United States
Completed
Rochester, 14642, United States
Completed
Minneapolis, 55455, United States
Completed
Worcester, 01655, United States
Completed
Charlotte, 28203, United States
Withdrawn
Shreveport, 71103, United States
Completed
Houston, 77030, United States
Completed
Valhalla, 10595, United States
Completed
Hospitalet de Llobregat, 08907, Spain
Completed
Lugo, 27003, Spain
Completed
Valencia, 46010, Spain
Completed
LEUVEN, 3000, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
LIEGE, 4000, Belgium
Completed
KORTRIJK, 8500, Belgium
Withdrawn
Durban, 2091, South Africa
Withdrawn
Port Elizabeth, 6045, South Africa
Completed
Cape Town, 7500, South Africa
Withdrawn
Ramat Gan, 5266202, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Melbourne, 3004, Australia
Completed
Randwick, 2031, Australia
Completed
Herston, 4029, Australia
Completed
Maywood, 60153-5585, United States
Completed
LYON, 69004, France
Completed
CRETEIL, 94010, France
Completed
MARSEILLE, 13005, France
Completed
LILLE, 59037, France
Completed
CLICHY, 92110, France
Completed
VANDOEUVRE-LES-NANCY, 54511, France
Completed
Pessac, 33604, France
Completed
Gdansk, 80-952, Poland
Completed
Bydgoszcz, 85-796, Poland
Completed
Warszawa, 02-781, Poland
Withdrawn
Reggio Emilia, 42123, Italy
Withdrawn
Bergamo, 24128, Italy
Completed
Madrid, 28040, Spain
Completed
Barcelona, 08036, Spain
Completed
Brisbane, 4120, Australia
Completed
Wien, 1090, Austria
Completed
Santiago, 7601003, Chile
Withdrawn
Temuco, Chile
Withdrawn
Cali, Colombia
Completed
Floridablanca, Colombia
Withdrawn
Bogotá, Colombia
Withdrawn
Heraklion, 711 10, Greece
Withdrawn
Athens, 11526, Greece
Completed
Larissa, 41100, Greece
Withdrawn
Athens, 11528, Greece
Completed
São Paulo, 05651-900, Brazil
Completed
Belo Horizonte, 30110-090, Brazil
Completed
Rio de Janeiro, 21941-913, Brazil
Withdrawn
Málaga, 29010, Spain
Withdrawn
San Sebastián de los Reyes, 28702, Spain
Completed
Santander, 39008, Spain
Withdrawn
Toronto, M5G 2M9, Canada
Completed
Montreal, H3A 1A1, Canada
Completed
Edmonton, T6G 1Z2, Canada
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
GENT, 9000, Belgium
Completed
LA LOUVIERE, 7100, Belgium
Completed
Johannesburg, 2193, South Africa
Completed
Zrifin, 70300, Israel
Completed
Haifa, 3109601, Israel
Completed
Rehovot, 7610001, Israel
Completed
Beer Sheva, 8410101, Israel
Completed
Clayton, 3168, Australia
Completed
Sao Paulo, 01509-900, Brazil
Withdrawn
Kazan, 420029, Russia
Withdrawn
Kemerovo, 650000, Russia
Withdrawn
Yaroslavl, 150054, Russia
Completed
Nizhny Novgorod, 603001, Russia
Completed
Beijing, 100021, China
Completed
Beijing, 100071, China
Completed
Hangzhou, 310016, China
Completed
Seoul, 05505, Korea, Republic Of
Completed
Taipei, 112, Taiwan
Completed
Taoyuan, 333, Taiwan
Completed
Tainan, 736, Taiwan
Completed
Lima, LIMA 1, Peru
Withdrawn
Lima, 01, Peru
Completed
Hong Kong, Hong Kong
Completed
Singapore, 169610, Singapore
Completed
Nedlands, 6009, Australia
Completed
Sofia, 1784, Bulgaria
Completed
Plovdiv, 4002, Bulgaria
Completed
Varna, 9002, Bulgaria
Completed
Varna, 9010, Bulgaria
Completed
Santiago, 838-0455, Chile
Withdrawn
Viña del Mar, Chile
Completed
Medellín, Colombia
Completed
Athens, 115 27, Greece
Completed
Thessaloniki, 54642, Greece
Completed
Thessaloniki, 546 36, Greece
Completed
Sao Paulo, 05403-000, Brazil
Completed
Porto Alegre, 90020-090, Brazil
Completed
Moscow, 115478, Russia
Withdrawn
St.Petersburg, Russia
Completed
Barnaul, 656049, Russia
Completed
Guangzhou, 510060, China
Completed
Nanjing, 210002, China
Completed
Seoul, 03080, Korea, Republic Of
Completed
Seoul, 06351, Korea, Republic Of
Completed
Goyang-si, 410-769, Korea, Republic Of
Completed
Seoul, 152-703, Korea, Republic Of
Completed
Lima, LIMA 34, Peru
Withdrawn
Lima, LIMA 27, Peru
Completed
Lima, LIMA 34, Peru
Completed
Shatin, Hong Kong
Completed
Singapore, 308433, Singapore
Completed
Auckland, 1023, New Zealand
Completed
Wellington South, 6021, New Zealand
Completed
Christchurch, 8011, New Zealand
Withdrawn
Heidelberg, 69120, Germany
Withdrawn
Bucaramanga, Colombia

Primary Outcome

  • Overall survival
    Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
    date_rangeTime Frame:
    From randomization of the first patient until 34 months or date of death of any cause whichever came first
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to radiological tumor progression (TTP)
    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.
    date_rangeTime Frame:
    From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Disease control
    Disease control was defined as the number of participants who had a best response rating of complete 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.
    date_rangeTime Frame:
    From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Health-related quality of life and utility values as measured by EQ-5D - Index
    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.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    No
  • Health-related quality of life and utility values as measured by EQ-5D - VAS
    Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.
    date_rangeTime 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.
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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