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Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Primary Purpose

Liver Cancer

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

temsirolimus

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire Henri Mondor

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Temsirolimus

Arm Description

Temsirolimus

Outcomes

Primary Outcome Measures

3-month disease-control rate according to RECIST criteria

Secondary Outcome Measures

3-month objective response rate according to RECIST criteria

Full Information

NCT ID

NCT01079767

First Posted

March 2, 2010

Last Updated

March 3, 2014

Sponsor

Federation Francophone de Cancerologie Digestive

1. Study Identification

Unique Protocol Identification Number

NCT01079767

Brief Title

Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Terminated

Why Stopped

The study treminated early according to DSMB recommendantions

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temsirolimus

Arm Type

Other

Arm Description

Temsirolimus

Intervention Type

Drug

Intervention Name(s)

temsirolimus

Primary Outcome Measure Information:

Title

3-month disease-control rate according to RECIST criteria

Time Frame

2010

Secondary Outcome Measure Information:

Title

3-month objective response rate according to RECIST criteria

Time Frame

2010

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Decaens, MD

Organizational Affiliation

Centre Hospitalier Universitaire Henri Mondor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christophe Duvoux

Organizational Affiliation

Centre Hospitalier Universitaire Henri Mondor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire Henri Mondor

City

Creteil

ZIP/Postal Code

94010

Country

France

12. IPD Sharing Statement

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Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

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