Clinical trial NCT01251458: Hepatocellular Carcinoma (HCC)_Torisel_
Official title: Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Inoperable HCC
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
* measurable disease
* Age \>=18 years.
* Life expectancy of greater than 12 weeks.
* ECOG performance status \<= 2
* Prior systemic therapy for HCC is allowed
* Adequate haematologic, renal and hepatic function
* Absence of cirrhosis or Child's A cirrhosis
* Fasting total cholesterol \<9.1 mmol/liter and fasting triglyceride level \<4.5 mmol/liter)

Exclusion Criteria:

* Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
* Patients receiving any other investigational agents concurrently.
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women.

Primary outcomes:
measure: • To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)
timeFrame: 2 years
Secondary outcomes:
measure: • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC
timeFrame: 2 Years
measure: • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®
timeFrame: 4 Years
measure: • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®
timeFrame: 2 years
measure: • To determine the response rate (CR and PR) based on RECIST criteria
timeFrame: 2 years
measure: • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)
timeFrame: 2 years
measure: • To determine duration of response (DR)
timeFrame: 2 years
measure: • To determine overall survival (OS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, The Chinese University of Hong Kong
name: Winnie Yeo, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: