Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01079767
Status:
TERMINATED
Last Update Posted:
2014-03-04
First Post:
2010-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Study Overview
Official Title:
Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study treminated early according to DSMB recommendantions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: