Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079767
• Other study ID #: CDR0000666229
• Secondary ID: FFCD-0903EUDRACT
• Status: Terminated
• Phase: Phase 2
• First received: March 2, 2010
• Last updated: March 3, 2014
• Start date: January 2010

Study information

• Verified date: March 2010
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• temsirolimus

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month disease-control rate according to RECIST criteria		2010	No
Secondary	3-month objective response rate according to RECIST criteria		2010	No