Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00539643

Collaborator

Columbia University (Other)

101

Enrollment

Location

Arms

175.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Liver Cancer Hepatoma	Device: Bead Block microspheres Other: Bead + Dox Arm	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jun 17, 2022

Actual Study Completion Date :

Jun 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bead Arm Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.	Device: Bead Block microspheres Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
Active Comparator: Bead + Dox Arm Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.	Other: Bead + Dox Arm Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Arm

Intervention/Treatment

Active Comparator: Bead Arm

Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.

Device: Bead Block microspheres

Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis

Active Comparator: Bead + Dox Arm

Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Other: Bead + Dox Arm

Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Outcome Measures

Primary Outcome Measures

Response to treatment by RECIST criteria [2 to 3 weeks]

Secondary Outcome Measures

Evaluate toxicity, time to progression (TTP) and survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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