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A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Liver Cancer, Hepatoma

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Trial Information

A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)


Biocompatibles LC Bead (also known as DC Bead in Asia & Europe) microspheres are preformed
soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood
flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA.
The fully polymerized microsphere is approximately 90% water and is compressible to
approximately 30% by diameter. The microspheres can be delivered through conventional
catheters (4-5Fr) or micro-catheters in the 2-3Fr range. These microspheres, like all agents
used for arterial embolization, are mixed with radiographic contrast prior to administration
in order to allow for fluoroscopic control of the embolization procedure.


Inclusion Criteria:



- Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis;
who is not a surgical resection candidate, or refuses surgery

- Patient must be 18 years of age or older

- Patient must be Okuda stage I or II

- Patient must have an ECOG performance status of 0 or 1

- No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with
all toxicities, if any, resolved to grade < than or = to 1

- Patient must have the following laboratory values confirmed within 14 days of
registration:

- Creatinine ≤ than or = to 2.0 the institution ULN

- Platelets ≥ than or = to 50,000/mm3

- INR ≤ than or = to 2.0 for patients who are not on Coumadin

- aPTT < or = to twice control

- Bilirubin < 3 mg/dl

- WBC > 3000 cells/mm3

- ANC > 1500 cells/mm3

- Negative serum pregnancy test (Female of childbearing potential only)

Exclusion Criteria:

- Patient has another primary tumor, with the exception of conventional basal cell CA,
superficial bladder cancer, melanoma in situ, or treated prostate cancer currently
without biochemical or radiographic evidence of active disease

- Women who are pregnant or lactating

- Patient previously treated with doxorubicin

- Contraindication to angiography/embolization including: patients who cannot receive
contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal
function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on
judgment of the investigator

- Patient has already undergone hepatic arterial embolization for the hepatocellular
cancer for which they are currently being evaluated

- Patient has received prior radiotherapy for the hepatocellular cancer for which they
are currently being evaluated

- Patient has had previous local-regional treatment of the current target tumor volume

- Patient who cannot have CT scan

- Patient at very high risk for post-embolization hepatic failure: 1. Child's C
cirrhosis, 2. > 75% liver replaced by tumor

- Cardiac exclusion for: 1. Myocardial infarction within 90 days of study, 2.
uncontrolled arrhythmia, 3. LVEF < 50% for patients randomized to receive LC Bead

- Patients with tumors exhibiting characteristics considered contra-indications to
particle embolization, including: 1. collateral vessel pathways potentially
endangering normal territories during embolization, 2. arteries supplying tumor not
large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic
venous shunts, 4. Presence of arterial to pulmonary vascular shunts

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Response to treatment by RECIST criteria

Outcome Time Frame:

2 to 3 weeks

Safety Issue:

No

Principal Investigator

Karen T Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

07-099

NCT ID:

NCT00539643

Start Date:

November 2007

Completion Date:

February 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Hepatoma
  • Liver Cancer
  • Hepatoma
  • 07-099
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Memorial Sloan-Kettering Cancer Center 1275 York AvenueNew York, New York  10021