Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019786

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

MedlinePlus related topics: Cancer Colorectal Cancer Liver Cancer Surgery

Drug Information available for: Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

H. Richard Alexander, MD, FACS

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000067220, NCI-99-C-0123
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00019786 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Melphalan
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Carcinoma, Neuroendocrine
Antineoplastic Agents
Gastrointestinal Diseases
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Colonic Diseases
Rectal Diseases
Liver Neoplasms
Neoplastic Processes
Neoplasms by Site

Pathologic Processes
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Alkylating Agents
Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Endocrine System Diseases
Adenoma, Islet Cell
Intestinal Diseases
Immunosuppressive Agents
Pharmacologic Actions
Intestinal Neoplasms
Carcinoma

ClinicalTrials.gov processed this record on November 09, 2009