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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,075
sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.
sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
San Diego, California, United States
Overall Survival (OS)
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Progression-Free Survival (PFS)
The period from randomization until disease progression or death.
Time frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Time to Tumor Progression (TTP)
Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\])
Time frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
European Quality of Life (EQ-5D)- Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state.
Time frame: Day 1 of each cycle
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Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Ringgold, Georgia, United States
Pfizer Investigational Site
Iowa City, Iowa, United States
Pfizer Investigational Site
Crestview Hills, Kentucky, United States
Pfizer Investigational Site
The Bronx, New York, United States
...and 161 more locations