RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.

Condition	Treatment or Intervention	Phase
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma liver metastases	Drug: cisplatin  Drug: doxorubicin  Drug: mitomycin  Procedure: chemotherapy  Procedure: embolization therapy  Procedure: hepatic arterial infusion	Phase II

Further Study Details: 

OBJECTIVES:

• Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization.
• Evaluate tumor response achievable with chemoembolization in this patient population.
• Evaluate the toxicities of this treatment in these patients.
• Evaluate survival of these patients following this treatment.
• Evaluate extrahepatic patterns of failure following chemoembolization, to determine whether intrahepatic progression may be forestalled and survival affected in these patients.
• Validate a consistent method of performing chemoembolization in a multicenter setting.

OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases).

Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.

In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Biopsy proven intrahepatic hepatocellular carcinoma or neuroendocrine hepatic metastases that are deemed unresectable
• Biopsy may be waived if there is known clinical cirrhosis or chronic hepatitis and alphafetoprotein greater than 500 ng/mL
• Bidimensionally measurable disease
• Evidence of patent portal vasculature by Doppler ultrasound, MRI, or angiography
• No evidence of extrahepatic disease that is likely to be life threatening within 3 months (e.g., brain or symptomatic lung metastases)

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count greater than 2,000/mm^3
• Platelet count greater than 50,000/mm^3

Hepatic

• Bilirubin less than 2.0 mg/dL

Renal

• Creatinine less than 2.0 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 2 months after study participation
• No concurrent active malignancy
• No history of life-threatening contrast allergy

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior intraarterial or intrahepatic chemotherapy
• At least 4 weeks since prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Georgia
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      Hinsdale Hematology Oncology Associates, Hinsdale,  Illinois,  60521,  United States; Recruiting
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting

Study chairs or principal investigators

Keith Ellis Stuart, MD,  Study Chair,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  CDR0000067083; ECOG-4298; NCT00003907
Record last reviewed:  February 2005
Last Updated:  March 3, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003907
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08