Clinical trial NCT00105443: A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Official title: A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: Liver Cancer
Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-03-15
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Detailed description: The following abbreviations were used in the Adverse Event section:

* international normalized ratio (inr)
* Common Terminology Criteria for Adverse Events (ctcae)
* Not Otherwise Specified (nos)
* Gastrointestinal (gi)
* Central nervous system (cns)
* Absolute Neutrophil Count (anc)
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Creatine phosphokinase (cpk)
* Gammaglutamyltransferase (ggt)
* Genitourinary (gu)
* Atrioventricular (av)

Eligibility criteria: Inclusion Criteria:

* Ages eligible for study: 18 years and above, Genders eligible for study: both
* Patients who have a life expectancy of at least 12 weeks
* Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
* Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
* Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2

Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]). Any cancer curatively treated \> 3 years prior to entry is permitted
* Renal failure requiring hemo- or peritoneal dialysis
* History of cardiac disease
* Active clinically serious infections
* Known history of human immunodeficiency virus (HIV) infection
* Known central nervous system tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
measure: Time to Symptomatic Progression (TTSP)
timeFrame: from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
measure: Disease Control (DC)
timeFrame: time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
measure: Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
timeFrame: from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Stanford
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Mar del Plata
country: Argentina
state: Buenos Aires
city: Pilar
country: Argentina
state: Buenos Aires
city: Bueno Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: San Miguel de Tucumán
country: Argentina
state: Tucuman
city: San Miguel de Tucumán
country: Argentina
state: Tucuman
city: Camperdown
country: Australia
state: New South Wales
city: Randwick
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: East Bentleigh
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Brugge
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Belo Horizonte
country: Brazil
city: Belo Horizonte
country: Brazil
city: Sao Paulo
country: Brazil
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Santiago de Chile
country: Chile
state: Santiago
city: Santiago de Chile
country: Chile
city: Santiago Región Metropolitana
country: Chile
city: Zagreb
country: Croatia
city: Bondy
country: France
city: Bordeaux
country: France
city: Clichy
country: France
city: Dijon
country: France
city: Lille Cedex
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Rennes Cedex
country: France
city: Vandoeuvre-les-nancy
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Haidari
country: Greece
state: Attica
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Haifa
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Zrifin
country: Israel
city: Rozzano
country: Italy
state: Milano
city: Avellino
country: Italy
city: Bologna
country: Italy
city: Forlì
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: México
country: Mexico
state: Distrito Federal
city: Monterrey
country: Mexico
city: México, D.F.
country: Mexico
city: México, D.F.
country: Mexico
city: Auckland
country: New Zealand
city: Wellington South
country: New Zealand
city: Comas Lima
country: Peru
city: Lima Cercado
country: Peru
city: Lima
country: Peru
city: Gdansk
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Timisoara
country: Romania
state: Timis
city: Craiova Dolj
country: Romania
city: Iasi
country: Romania
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tolgliatti
country: Russian Federation
city: Badalona
country: Spain
state: Barcelona
city: Cruces/Barakaldo
country: Spain
state: Bilbao
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Zürich
country: Switzerland
city: Bristol
country: United Kingdom
state: Avon
city: Oxford
country: United Kingdom
state: Oxfordshire
city: Glasgow
country: United Kingdom
state: Stratchclyde
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle-upon-Tyne
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
citation: Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4.