Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver

NCT00020501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-03-08

No results posted yet for this study

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. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.

Conditions

Interventions

DRUG

FOLFIRI regimen

DRUG

floxuridine

DRUG

irinotecan hydrochloride

DRUG

leucovorin calcium

DRUG

melphalan

PROCEDURE

hyperthermia treatment

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • H. Richard Alexander, MD, FACS · NCI - Surgery Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Completion
2005-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00020501 on ClinicalTrials.gov