A Phase I/II, Open Label, Multicenter, Single-Arm, Safety and Efficacy Study of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers (MTC-DOX) Administered by Intrahepatic Delivery (Via Hepatic Artery Catheterization) for the Treatment of Patients With Unresectable Hepatocellular Carcinoma.
Patients may be enrolled into this protocol only if all of the following inclusion
criteria are met:
- Patient has unresectable hepatocellular carcinoma diagnosed by CT scan and meets
criteria described in Section 23.
- Total combined cross-sectional area of all hepatic tumors as determined by CT scan is
between 4 and 150 cm2.
- The center of the tumor(s) mass must be less than or equal to 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.
- Patient is ambulatory with a Karnofsky performance status score greater than or equal
to 60 and an estimated life expectancy of greater than or equal to 3 months.
- Patient is between 18 and 80 years old.
- Patient 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.
- Patient or legal representative has the ability to give informed written consent
prior to initiation of therapy.
- If patient is female and of childbearing potential, she must have a negative b-HCG
prior to receiving treatment.
- Patient must agree to use an effective method of contraception (e.g., birth control
pills, condoms, intrauterine device, diaphragm, Norplant, Depo-Provera).
Patients will be excluded from enrollment if any of the following apply:
- Patient 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).
- Patient has had prior radiation therapy within the last 6 months or chemotherapy
within the last 4 weeks.
- Patients with diffuse hepatocellular carcinoma or disease that precludes delivery of
the drug to the tumor via a vessel that feeds the tumor.
- Patient 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 < 3,500/uL Platelets < 40,000/ul Hemoglobin < 9.5 gm/dL Total bilirubin > 2.5 mg/dL
ALT or AST > or equal to 5 x upper limit of normal Serum Creatinine > 2.0 mg/dL INR > or
equal to 2.0
- Patient has cardiac dysfunction with a left ventricular ejection fraction < 40%.
- Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal
and/or biological treatment for cancer including immunotherapy (excluding megace,
oral contraceptives or post menopausal estrogen replacement therapy) while on study.
- Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other
indwelling device or appliance that could be adversely affected by the use of the
- Patients with documented evidence of hemachromatosis or hemosiderosis.
- Patients with CT or Ultrasound evidence of main or first branch portal vein invasion
- Prior orthotopic hepatic transplant.
- Patient has received previous treatment with doxorubicin, idarubicin, and/or other
anthracyclines or anthracenes.
- Patient has a known allergy to doxorubicin, MTC-DOX or any of their components.
- Patient has been treated with any investigational drug, investigational biologic, or
investigational therapeutic device within 30 days of initiating study treatment.