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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

Phase 2
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

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

OBJECTIVES: I. Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel
(Intradose MPI-5010) in patients with unresectable primary hepatocellular carcinoma.

OUTLINE: This is an open label, two stage, multicenter study. Patients receive intratumoral
treatment with ciplatin-epinephrine (MPI-5010) once weekly, for up to four treatments within
a six week period, followed by an evaluation two weeks after last treatment. Immediately
after the first course, an optional second course of treatment may be undertaken at the
discretion of the investigator. Patients with a complete response, partial response, and/or
an increase in necrosis of at least 30% of total treated tumor volume will be followed
monthly for up to 6 months. At the completion of 6 months follow up or following
documentation of disease progression or development of new tumors, patients are monitored
for survival in an extended follow up period. All nonresponders at the last 2 week
posttreatment evaluation are entered in the extended follow up and monitored monthly for

PROJECTED ACCRUAL: Up to 55 patients will be accrued for this study.

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard D. Leavitt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Matrix Pharmaceutical


United States: Federal Government

Study ID:




Start Date:

September 1996

Completion Date:

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Johns Hopkins Oncology Center Baltimore, Maryland  21287