Overview

Chemotherapy in Treating Patients With Liver Cancer

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Matrix Pharmaceutical

Treatments:

Cisplatin
Epirubicin

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