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Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

2014-07-23 21:09:56 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

temsirolimus, laboratory biomarker analysis, pharmacological study, quality-of-life assessment, fludeoxyglucose F 18

Location

Centre Hospitalier Universitaire Henri Mondor
Creteil
France
94010

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:56-0400

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