Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Registration Number
- NCT00699374
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1075
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B sorafenib sorafenib arm Arm A sunitinib malate sunitinib arm
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 The period from randomization until disease progression or death.
Time to Tumor Progression (TTP) Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 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 \[PD\])
European Quality of Life (EQ-5D)- Health State Profile Utility Score Day 1 of each cycle 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧London, United Kingdom