A Two-Stage Phase II Safety and Efficacy Study of IntraDose (Cisplatin/Epinephrine) Injectable Gel (MPI 5010) Administered to Patients With Unresectable Primary Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable primary hepatocellular
carcinoma No major vessel involvement Disease must be confined to the liver (no
extrahepatic disease) Patients have no more than 3 tumors, with no tumor exceeding 7 cm in
diameter, and the sum total tumor volume less than 200 cm3

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 40-100% Life
Expectancy: At least 4 months Hematopoietic: Hemoglobin at least 10 g/dL Platelet count at
least 75,000/mm3 Absolute granulocyte count at least 1,000/mm3 PT within 3 seconds of
institutional norm Hepatic: SGPT no greater than 3 times upper limit of normal (ULN) SGOT
no greater than 3 times ULN Child-Pugh grade A or B Albumin at least 25 g/L Bilirubin no
greater than 2.98 mg/dL Absent or easily controlled ascites not requiring routine or
intermittent paracentesis Alkaline phosphatase no greater than 2.5 times ULN Renal:
Creatinine no greater than 1.3 times ULN OR Creatinine clearance at least 45 mL/min
Cardiovascular: No coronary artery disease No New York Heart Association class III or
greater cardiac symptoms Other: Not pregnant or nursing No medical or psychiatric
condition compromising informed consent No obesity or tumor location that would limit
adequate tumor imaging No history of bleeding from liver tumor(s) or gastroesophageal
bleeding No known hypersensitivity to cisplatin, bovine collagen, epinephrine, sulfites or
radiographic contrast agents No history of encephalopathy

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for hepatocellular
carcinoma No concurrent immunomodulating agents Chemotherapy: No prior or concurrent
chemotherapy for hepatocellular carcinoma No concurrent cytotoxic agents Endocrine
therapy: No prior endocrine therapy for hepatocellular carcinoma Radiotherapy: No prior
radiotherapy for hepatocellular carcinoma Surgery: Prior surgical resection of the liver
allowed Other: No concurrent use of aspirin, nonsteroidal anti-inflammatory agents,
anticoagulants including warfarin sodium (Coumadin), and epinephrine containing
medications including topical anesthetics such as bupivacaine HCl No prior investigational
agents within 4 weeks of study No concurrent use of probenecid or thiazides Concurrent use
of analgesics and antiemetics is allowed Concurrent use of topical and other local
anesthetics, locoregional nerve blocks, and systemic agents is allowed