Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Liver Cancer; Hepatoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: Bead Block microspheres; Bead + Dox Arm
Intervention description: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cancer; Hepatoma; 07-099

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.
    

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