Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases

National Institutes of Health Clinical Center (CC)

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Islet Cell Tumor; Neuroendocrine Carcinoma; Liver Cancer; Colorectal Cancer

Treatments: Procedure: conventional surgery; Drug: isolated perfusion; Drug: melphalan

Study type: Interventional

Funder types: NIH

Identifiers

NCT00019786

99-C-0123

CDR0000067220

990123

Details and patient eligibility

About

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: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.

Full description

OBJECTIVES:

• Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
• Determine the disease-free and overall survival of patients treated with this regimen.

OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.

Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.

PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.

Enrollment: 67 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven liver cancer meeting 1 of the following criteria:

  • Primary unresectable hepatocellular or cholangiocellular carcinoma

  • Metastatic cancer to the liver originating from one of the following:

    • Intraocular melanoma (closed to accrual as of 10/17/03)

    • Islet cell carcinoma

    • Adenocarcinoma of the colon or rectum limited to parenchyma of the liver

      • No evidence of other unresectable extrahepatic colorectal metastasis

  • Other neuroendocrine tumors, such as carcinoid tumors

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 100,000/mm^3
• Hematocrit greater than 27.0%
• WBC at least 2,500/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
• PT no greater than 2 seconds above upper limit of normal
• Elevated SGOT and SGPT allowed if not due to hepatitis
• No biopsy-proven cirrhosis or evidence of significant portal hypertension
• No prior or concurrent veno-occlusive disease
• Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Congestive heart failure allowed if LVEF ≥ 40%

Pulmonary:

• No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age

Other:

• Weight greater than 30 kg
• Not pregnant or nursing
• Negative pregnancy test
• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 month since prior anticancer biologic therapy and recovered

Chemotherapy:

• At least 1 month since prior anticancer chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since prior anticancer radiotherapy and recovered

Surgery:

• Not specified

Other:

• Prior intrahepatic arterial infusion therapy allowed
• No chronic use of anticoagulants
• No concurrent immunosuppressive therapy