Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

3-month disease-control rate according to RECIST criteria

Safety Issue:

No

Principal Investigator

Thomas Decaens, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire Henri Mondor

Authority:

Unspecified

Study ID:

CDR0000666229

NCT ID:

NCT01079767

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Fibrosis
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location