Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)|
- 3-month disease-control rate according to RECIST criteria [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- 3-month objective response rate according to RECIST criteria [ Time Frame: 2010 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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.
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94010|
|Principal Investigator:||Thomas Decaens, MD||Centre Hospitalier Universitaire Henri Mondor|
|Principal Investigator:||Christophe Duvoux||Centre Hospitalier Universitaire Henri Mondor|