None listed
Conditions
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.
Interventions
This is a randomized, double blinded trial to evaluate the clinical benefit of sorafenib 400 mg bid versus placebo in patients with advanced HCC (Child-Pugh A only).
The overall treatment period will be divided into 6-week cycles.
Patient visits for safety and drug accountability will be conducted every 3 weeks. The Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) Questionnaire will also be completed every three weeks.
The FHSI-8 and FACT-Hep questionna
This is a randomized, double blinded trial to evaluate the clinical benefit of sorafenib 400 mg bid versus placebo in patients with advanced HCC (Child-Pugh A only). The overall treatment period will be divided into 6-week cycles. Patient visits for safety and drug accountability will be conducted every 3 weeks. The Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) Questionnaire will also be completed every three weeks. The FHSI-8 and FACT-Hep questionnaires are being completed as part of an assessment of efficacy endpoints. Tumor measurements will be conducted on the first day of each cycle. After study drug treatment ends, patients will be contacted every 3 months to determine survival status and to request that they complete the FHSI-8. Recruitment is expected to be achieved by April 2006.
Sponsors
Bayer Australia Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have a life expectancy of at least 12 weeks.Patients with advanced HCC. Patients with histologically or cytologically documented HCC. Patients must have at least one tumor lesion that can be accurately measured in at least one dimension and has not been previously treated with local therapy.
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, Tis & T1). 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.History of organ allograft.Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.Known or suspected allergy to the investigational agent or any agent given in association with this trial.Patients unable to swallow oral medications.Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the studyPregnant or breast-feeding patients.
Outcome results
None listed