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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019786
• Other study ID #: 990123
• Secondary ID: 99-C-0123CDR0000
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: March 21, 2012
• Start date: August 1999
• Est. completion date: January 2006

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001820

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Colorectal Cancer
• Islet Cell Tumor
• Liver Cancer
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Neuroendocrine Carcinoma

Intervention

Drug:
• isolated perfusion

• melphalan

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Feldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Duration of response			No
Primary	Patterns of recurrence			No
Primary	Disease-free survival			No
Primary	Overall survival			No