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

October 27, 2023 updated by: National Institutes of Health Clinical Center (CC)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

PROJECTED ACCRUAL:

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

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Surgery Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

PROTOCOL ENTRY CRITERIA:

--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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Investigators

  • Study Chair: H. Richard Alexander, Jr., National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Study Completion (Actual)

March 1, 2002

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimated)

March 5, 2007

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990093
  • 99-C-0093
  • CDR0000067199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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