SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

This study has been terminated.
(low patient recruitment)
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT00503867
First received: July 18, 2007
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.


Condition Intervention Phase
Carcinoma, Hepatocellular
Hepatoma
Device: SIR-Spheres microspheres
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sirtex Medical:

Primary Outcome Measures:
  • safety and toxicity [ Time Frame: for 24 weeks after most recent SIRT treatment, and until death whenever possible ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: from the date of enrollment to the date of documented progression ] [ Designated as safety issue: No ]
  • tumor response [ Time Frame: from the date of enrollment to disease progression or death ] [ Designated as safety issue: No ]
  • health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: from the date of enrollment to disease progression or death ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SIR-Spheres microspheres
    SIR-Spheres Yttrium-90 microspheres
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must have a confirmed diagnosis of HCC.
  • at least 18 years of age.
  • must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 UI/ml.
  • must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.
  • must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).
  • must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70%
  • must have an ECOG performance status of 2 or less.
  • must have normal organ and marrow function

Exclusion criteria:

Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study:

  • hepatic artery directed therapy within the previous 6 months.
  • chemotherapy within the previous 4 weeks
  • have not recovered from adverse events due to agents administered previously
  • Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC
  • Currently receiving any other investigational agents for the treatment of their cancer.
  • Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting.
  • Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any of the following contraindications to angiography and selective visceral catheterization:

    • Bleeding diathesis
    • Severe peripheral vascular disease
    • Portal hypertension with hepatofugal flow
  • Female subjects who are pregnant or currently breastfeeding.
  • Refusal or inability to use effective means of contraception in men or women of childbearing potential.
  • Current enrollment in any other investigational drug or device study.
  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: NCT00503867

Locations
United States, Pennsylvania
Thomas Jefferson University - Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
UPMC Liver Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sirtex Medical
Investigators
Principal Investigator: Ravi Murthy, MD M.D. Anderson Cancer Center
Principal Investigator: T. Clark Gamblin, MD UPMC Liver Cancer Center
  More Information

No publications provided

Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT00503867     History of Changes
Other Study ID Numbers: STX 0106
Study First Received: July 18, 2007
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sirtex Medical:
unresectable hepatocellular carcinoma
HCC
SIR-Spheres
Y-90 Microspheres
brachytherapy
SIRT
liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 22, 2014