Clinical trial NCT00539643: Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma
Official title: A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Liver Cancer
Hepatoma
Keywords: Liver Cancer
Hepatoma
07-099
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2007-10-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response to Treatment by RECIST Criteria
timeFrame: 2 to 3 weeks
Secondary outcomes:
measure: Number of Participants Evaluated for Toxicity
timeFrame: 1 year
measure: Progression Free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Karen T Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown KT, Do RK, Gonen M, Covey AM, Getrajdman GI, Sofocleous CT, Jarnagin WR, D'Angelica MI, Allen PJ, Erinjeri JP, Brody LA, O'Neill GP, Johnson KN, Garcia AR, Beattie C, Zhao B, Solomon SB, Schwartz LH, DeMatteo R, Abou-Alfa GK. Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol. 2016 Jun 10;34(17):2046-53. doi: 10.1200/JCO.2015.64.0821. Epub 2016 Feb 1.