Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Phase 2

Terminated

• Conditions: Liver Cancer
• Interventions: Drug: temsirolimus

• Registration Number: NCT01079767
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief 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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2010-12
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temsirolimus	temsirolimus	Temsirolimus

Primary Outcome Measures

Name	Time	Method
3-month disease-control rate according to RECIST criteria	2010

Secondary Outcome Measures

Name	Time	Method
3-month objective response rate according to RECIST criteria	2010

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France