Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT01079767

First received: March 2, 2010

Last updated: NA

Last verified: March 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 2, 2010

Last Updated Date

March 2, 2010

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

3-month disease-control rate according to RECIST criteria [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

3-month objective response rate according to RECIST criteria [ Designated as safety issue: No ]
1-month metabolic response rate on PET/CT scan [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Disease-free progression survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Clinical and biological tolerance [ Designated as safety issue: No ]
Rate of m-TOR pathway activation and VEGF level [ Designated as safety issue: No ]
Pharmacokinetics [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Liver Cancer

Intervention ^ICMJE

Drug: temsirolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: quality-of-life assessment
Radiation: fludeoxyglucose F 18

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01079767

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Federation Francophone de Cancerologie Digestive

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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