Liver Cancer Clinical Trial
Official title:
Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients
with advanced liver cancer and cirrhosis.
OBJECTIVES:
Primary
- To determine the 3-month disease-control rate according to RECIST criteria in patients
with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis.
Secondary
- To determine the 3-month objective response rate according to RECIST criteria in these
patients.
- To determine the 1-month metabolic response rate on PET/CT scan in these patients.
- To determine the 1-month perfusion response rate on hepatic perfusion CT scan in these
patients.
- To determine the time to progression in patients treated with this drug.
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To assess quality of life according to QLQ-C30 and QLQ-HCC18 questionnaires.
- To determine the clinical and biological tolerance of this drug in these patients.
- To determine the rate of m-TOR pathway activation and VEGF level.
- To evaluate the pharmacokinetics of this drug in select patients.
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30-60 minutes on day 1. Treatment repeats once a week
in the absence of disease progression or unacceptable toxicity. Patients also undergo
fludeoxyglucose F 18 (FDG) positron emission tomography/computed tomography (PET/CT) scan
and perfusion CT scan of the liver at baseline and periodically during study treatment.
Patients complete quality of life questionnaires (QLC-C30 and QLQ-HCC18) periodically. Some
patients undergo blood and tissue sample collection periodically for pharmacological and
laboratory studies.
After completion of study therapy, patients are followed for up to 24 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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