Clinical trial NCT00699374: Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
Official title: A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: sunitinib
phase 3
randomized
hepatocellular
liver
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 1075
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 study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Detailed description: This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.

Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed diagnosis of hepatocellular carcinoma
* presence of measurable disease by radiographic imaging
* Child-Pugh class A
* ECOG PS 0 or 1
* adequate organ function.

Exclusion Criteria:

* Prior treatment with any systemic treatment for hepatocellular carcinoma
* prior local treatment within 4 weeks from entry
* presence of clinically relevant ascites
* severe hemorrhage \<4 weeks of starting study treatment
* known HIV or serious acute or chronic illness
* current treatment on another clinical trial
* pregnancy or breastfeeding

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
measure: Time to Tumor Progression (TTP)
timeFrame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
measure: European Quality of Life (EQ-5D)- Health State Profile Utility Score
timeFrame: Day 1 of each cycle
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ringgold
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hixson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Mechanicsville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Concord
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Woodville South
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Hefei
country: China
facility: Pfizer Investigational Site
state: Anhui
city: Fuzhou City
country: China
facility: Pfizer Investigational Site
state: Fujian
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Nanning
country: China
facility: Pfizer Investigational Site
state: Guangxi
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Chengdu
country: China
facility: Pfizer Investigational Site
state: Sichuan
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Bejing
country: China
facility: Pfizer Investigational Site
city: Chong qing
country: China
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
city: Nanjing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Amiens Cedex 1
country: France
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Clichy Cedex
country: France
facility: Pfizer Investigational Site
city: Creteil Cedex
country: France
facility: Pfizer Investigational Site
city: Lille Cedex
country: France
facility: Pfizer Investigational Site
city: Nice Cedex 2
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: St Herblain Cedex
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Pfizer Investigational Site
city: Villejuif Cedex
country: France
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Hong Hong
country: Hong Kong
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Tuen Mun, New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Meldola
country: Italy
facility: Pfizer Investigational Site
state: FC
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Cattolica (RN)
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Ravenna
country: Italy
facility: Pfizer Investigational Site
city: Rimini
country: Italy
facility: Pfizer Investigational Site
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Chiba city
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kurume city
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Pfizer Investigational Site
state: Gifu
city: Sapporo-shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kanazawa city
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
city: Omura-shi
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Osaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka-fu
city: Osaka-Sayama
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Izunokuni-shi
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Okayama
country: Japan
facility: Pfizer Investigational Site
city: Chonju
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Chonbuk
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Lembah Pantai
country: Malaysia
facility: Pfizer Investigational Site
state: Kuala Lumpur
city: Subang Jaya
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
state: Cebu
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
city: Davao City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Pyatigorsk
country: Russian Federation
facility: Pfizer Investigational Site
city: St.Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Illes Balears
city: El Palmar
country: Spain
facility: Pfizer Investigational Site
state: Murcia
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Pu-Tz City
country: Taiwan
facility: Pfizer Investigational Site
state: Chai-Yi
city: Kwei-Shan
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan
city: Changhua
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung City
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Bangkok Noi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Ptumwan
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Amphoe Mueang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambridgeshire
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.
citation: Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.
citation: Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovacs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.