NCT01079767

Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	temsirolimus

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• First posted: 2010-03-03
• Last updated: 2014-03-04

Locations

1 site across 1 country: France