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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00019786

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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: 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Islet Cell Tumor Liver Cancer Metastatic Cancer Neuroendocrine Carcinoma	Drug: isolated perfusion Drug: melphalan Procedure: conventional surgery	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

67 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver

Study Start Date :

Aug 1, 1999

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Response rate []
Duration of response []
Patterns of recurrence []
Disease-free survival []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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