NCT00020501

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

First QC Date

July 11, 2001

Last Update Submit

March 7, 2012

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerliver metastases

Interventions

FOLFIRI regimenDRUG
floxuridineDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG
melphalanDRUG
hyperthermia treatmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver * No evidence of extrahepatic disease (limited resectable extrahepatic disease allowed) * Unresectable liver metastasis, as defined by the following: * More than 3 sites of disease * Bilobar disease * Tumor abutting major vascular or ductal structures * Measurable disease * No biopsy-proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices, or collateral vessels around organs drained by the portal venous system PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 27.0% * WBC greater than 3,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * PT no greater than 2 seconds over upper limit of normal * Elevations in transaminases secondary to metastatic disease allowed * No veno-occlusive disease * No active chronic hepatitis * Hepatitis B or C allowed 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: * No ischemic cardiac disease * No prior congestive heart failure with LVEF less than 40% Pulmonary: * No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function test less than 50% of predicted Other: * No active infections * Not pregnant or nursing * Negative pregnancy test * Weight greater than 30 kg PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy for disease and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy for disease and recovered * No prior intrahepatic artery infusion therapy with floxuridine Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy for disease and recovered Surgery: * Not specified Other: * No concurrent immunosuppressive drugs * No concurrent chronic anticoagulants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

FloxuridineFluorouracilIrinotecanLeucovorinMelphalanDiathermy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesUracilPyrimidinonesCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsHyperthermia, InducedTherapeutics

Study Officials

  • H. Richard Alexander, MD, FACS

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Study Completion

January 1, 2005

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)