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RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- To determine the 3-month disease-control rate according to RECIST criteria in patients with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis.
- 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, Primary Purpose: Treatment
temsirolimus, laboratory biomarker analysis, pharmacological study, quality-of-life assessment, fludeoxyglucose F 18
Centre Hospitalier Universitaire Henri Mondor
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:09:56-0400
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