Isolated Hepatic Perfusion With Melphalan Followed By Chemotherapy in Treating Patients With Unresectable Colorectal Cancer That is Metastatic to the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00019760
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : March 23, 2012
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of melphalan given as an isolated hepatic perfusion followed by chemotherapy infused into the liver in patients who have unresectable colorectal cancer that is metastatic to the liver.

Condition or disease Intervention/treatment Phase
Recurrent Colon Cancer Liver Metastases Stage IV Rectal Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Drug: floxuridine Drug: leucovorin calcium Drug: melphalan Phase 2

Detailed Description:

OBJECTIVES: I. Determine the response rate and response duration in patients with unresectable colorectal cancer metastatic to the liver treated with isolated hepatic perfusion with melphalan followed by postoperative hepatic arterial chemotherapy.

II. Determine the patterns of recurrence in this patient population with this treatment regimen.

III. Evaluate the disease-free survival and overall survival in these patients.

IV. Evaluate health related quality of life and determine whether baseline correlates with the length of survival.

PROTOCOL OUTLINE: Patients undergo surgery and hyperthermic isolated hepatic perfusion with melphalan given intra-arterially over 60 minutes.

At six weeks post-hepatic perfusion, patients receive floxuridine and leucovorin calcium intra-arterially as a continuous infusion over 14 days. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to study and then at each followup visit. Patients are followed every 3-4 months for 3 years and then every 6 months thereafter or until disease progression.


A total of 50 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of Isolated Hepatic Perfusion With Melphalan Followed By Postoperative Hepatic Arterial Chemotherapy in Patients With Unresectable Colorectal Cancer Metastatic to the Liver
Study Start Date : April 1999
Actual Study Completion Date : March 2002

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Ages Eligible for Study:   Child, Adult, Older Adult


--Disease Characteristics-- Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver No evidence of unresectable extrahepatic disease Limited resectable extrahepatic disease allowed Unresectable liver disease defined as: Greater than 3 sites of liver disease OR Bilobar disease OR Tumor abutting major vascular or ductal structures, impeding resection with preservation of liver function OR Limited extrahepatic disease No biopsy-proven cirrhosis No significant portal hypertension --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy for colorectal cancer and recovered Chemotherapy: At least 4 weeks since prior chemotherapy for colorectal cancer and recovered No prior intrahepatic arterial infusional therapy using floxuridine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy for colorectal cancer and recovered Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs No concurrent chronic anticoagulants --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm3 Hematocrit greater than 27.0% WBC greater than 3,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL PT no greater than 2 seconds over upper limit of normal Elevated hepatic transaminases secondary to liver metastases allowed No veno-occlusive disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No congestive heart failure with LVEF less than 40% Pulmonary: No chronic obstructive pulmonary disease No other chronic pulmonary disease with pulmonary function test less than 50% predicted Other: No active infections HIV negative Body weight greater than 30 kg Not pregnant or nursing Negative pregnancy test

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00019760

United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Study Chair: H. Richard Alexander, Jr. National Cancer Institute (NCI) Identifier: NCT00019760     History of Changes
Obsolete Identifiers: NCT00001809
Other Study ID Numbers: 990093
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
adult solid tumor
body system/site cancer
colon cancer
colorectal cancer
gastrointestinal cancer
genetic condition
liver and intrahepatic biliary tract cancer
liver metastases
metastatic cancer
rectal cancer
recurrent colon cancer
recurrent rectal cancer
site, metastatic cancer
solid tumor
stage IV colon cancer
stage IV rectal cancer
stage, colon cancer
stage, rectal cancer
unclassified/other cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Antimetabolites, Antineoplastic