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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019786
First received: July 11, 2001
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 67
Study Start Date: August 1999
Study Completion Date: January 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019786

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: H. Richard Alexander, MD, FACS NCI - Surgery Branch
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00019786     History of Changes
Obsolete Identifiers: NCT00001820
Other Study ID Numbers: 990123, 99-C-0123, CDR0000067220
Study First Received: July 11, 2001
Last Updated: March 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent islet cell carcinoma
adult primary hepatocellular carcinoma
adenocarcinoma of the colon
adenocarcinoma of the rectum
liver metastases
adult primary cholangiocellular carcinoma
advanced adult primary liver cancer
recurrent childhood liver cancer
childhood hepatocellular carcinoma
stage III childhood liver cancer
stage IV childhood liver cancer
neuroendocrine carcinoma

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Carcinoma, Neuroendocrine
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Adenoma
Pancreatic Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014