SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

NCT00503867 | Terminated Results DMC

• 1 other identifier: STX 0106
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular; Hepatoma

Keywords

unresectable hepatocellular carcinoma; HCC; SIR-Spheres; Y-90 Microspheres; brachytherapy; Selective Internal Radiation Therapy (SIRT); liver cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Grade 3 or Higher

  Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.

  From date of enrollment until the date of death from any cause assessed up 24 weeks.

Secondary Outcomes (4)

• Time to Disease Progression

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

• Tumor Response Rate

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

• Change From Baseline in Health-related Quality of Life

  52 weeks

• Overall Survival

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Study Arms (1)

SIR-Spheres microspheres

EXPERIMENTAL

SIR-Spheres microspheres

Device: SIR-Spheres microspheres

Interventions

SIR-Spheres microspheres DEVICE

SIR-Spheres Yttrium-90 microspheres

SIR-Spheres microspheres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 International Units/milliliter (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 Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
• must have normal organ and marrow function

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirtex Medical: lead

Study Sites (4)

Thomas Jefferson University - Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sirtex Medical

dcade@sirtex.com

011 61 2 9964 8470

Study Officials

• Ravi Murthy, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• T. Clark Gamblin, MD

  UPMC Liver Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 19, 2007
• Study Start: July 18, 2007
• Primary Completion: March 9, 2010
• Study Completion: March 9, 2010
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)