Study of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers (MTC-DOX) Administered by Intrahepatic Delivery Versus Intravenous Doxorubicin for Treatment of Patients With Unresectable Hepatocellular Carcinoma
Patients may be enrolled into this protocol only if all of the following inclusion
criteria are met:
- Unresectable hepatocellular carcinoma diagnosed by CT scan and meets the criteria
described in Section 23.
- Total combined cross-sectional area of all hepatic tumors as determined by CT scan is
between 4 and 200 cm2.
- Center of the tumor(s) mass must be = 14 cm from the anterior lateral abdominal
wall as determined by cross-sectional imaging at baseline. This is required for
optimal placement of the magnet. If more than one tumor mass is present, all of the
tumor masses must meet this criterion.
- Is ambulatory with a Karnofsky performance status score > 60 and an estimated life
expectancy of > 3 months.
- Is judged by the investigator to have the initiative and means to be compliant with
the protocol and be within geographical proximity to allow follow-up.
- Have the ability to give informed written consent prior to initiation of therapy.
- If female and of childbearing potential,must have a negative beta-HCG prior to
- Must agree to use an effective method of contraception
Patients will be excluded from enrollment if any of the following apply:
- Has a history of cancer other than hepatocellular (excluding resected basal cell
carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for
5 years or more).
- Has had prior local radiation therapy within the last 4 weeks, mediastinal radiation
therapy within the last 3 months, or chemotherapy within the last 4 weeks.
- Diffuse hepatocellular carcinoma or disease that precludes delivery of the drug to
the tumor via a vessel that feeds the tumor.
- Has another active medical condition(s) or organ disease(s) that may either
compromise patient safety or interfere with the safety and/or outcome (e.g.,
survival) evaluation of the study drugs. While this exclusion is not limited to the
following abnormalities, if any of the following laboratory abnormalities are
present, the patient should be excluded:
WBC < 2,000 /uL Platelets < 50,000/uL Hemoglobin < 8.0 gm/dL Total bilirubin > 3.0 mg/dL
ALT or AST >/= 5 x upper limit of normal Serum Creatinine >2.0 mg/dL INR >/= 1.5
- Has cardiac dysfunction with a left ventricular ejection fraction < 40%.
- Has clinically significant pulmonary impairment
- Plans concomitant chemotherapy, radiation therapy, hormonal and/or biological
treatment for cancer including immunotherapy while on study.
- Has an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling
device or appliance that could be adversely affected by the use of the external
- Has documented evidence of hemachromatosis or hemosiderosis.
- Has CT or ultrasound evidence of portal vein invasion or thrombosis.
- Prior orthotopic hepatic transplant.
- Has received previous treatment with doxorubicin, idarubicin, and/or other
anthracyclines or anthracenes.
- Has a known allergy to doxorubicin, MTC-DOX or any of their components.
- Has been treated with any investigational drug, investigational biologic, or
investigational therapeutic device within 30 days of initiating study treatment.