Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

March 3, 2014 updated by: Federation Francophone de Cancerologie Digestive

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria

    • Advanced disease
    • Must be morphologically evaluable
  • HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy
  • CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume)

  • Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria:

    • Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy
  • Not a candidate for transplantation and has not received a liver transplant

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Platelet count ≥ 50,000/mm^3
  • Neutrophil count ≥ 1,500/mm^3
  • Creatinine clearance ≥ 60 mL/min
  • GFR ≥ 30 mL/min
  • Serum cholesterol ≤ 350 mg/dL
  • Triglycerides ≤ 300 mg/dL
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy
  • No history of other cancer on treatment
  • No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction
  • No active infection except for viral hepatitis
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5
  • At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC
  • At least 6 months since prior chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Temsirolimus
Drug: temsirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-month disease-control rate according to RECIST criteria
Time Frame: 2010
2010

Secondary Outcome Measures

Outcome Measure
Time Frame
3-month objective response rate according to RECIST criteria
Time Frame: 2010
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Thomas Decaens, MD, Centre Hospitalier Universitaire Henri Mondor
  • Principal Investigator: Christophe Duvoux, Centre Hospitalier Universitaire Henri Mondor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000666229
  • FFCD-0903
  • EUDRACT-2009-014443-36
  • EU-21004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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