Hepatocellular Carcinoma (HCC)_Torisel_

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01251458
First received: December 1, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Inoperable HCC
Drug: Torisel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • • 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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel® [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • • To determine the response rate (CR and PR) based on RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • • To determine duration of response (DR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • • To determine overall survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Torisel Drug: Torisel
Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251458

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Winnie Yeo, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01251458     History of Changes
Other Study ID Numbers: HCC022
Study First Received: December 1, 2010
Last Updated: July 22, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014