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Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
This study is ongoing, but not recruiting participants.
Study NCT00019786   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
August 1999
 
  • Response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Patterns of recurrence [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Response rate
  • Duration of response
  • Patterns of recurrence
  • Disease-free survival
  • Overall survival
Complete list of historical versions of study NCT00019786 on ClinicalTrials.gov Archive Site
 
 
 
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Colorectal Cancer
  • Islet Cell Tumor
  • Liver Cancer
  • Metastatic Cancer
  • Neuroendocrine Carcinoma
  • Drug: isolated perfusion
  • Drug: melphalan
  • Procedure: conventional surgery
 
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 and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
67
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019786
 
CDR0000067220, NCI-99-C-0123
National Cancer Institute (NCI)
 
Study Chair: H. Richard Alexander, MD, FACS NCI - Surgery Branch
National Cancer Institute (NCI)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP