NCT00019760

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1999

Typical duration for phase_2

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

April 1, 1999

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
Last Updated

October 31, 2023

Status Verified

March 1, 2012

First QC Date

March 2, 2007

Last Update Submit

October 27, 2023

Conditions

Recurrent Colon CancerLiver MetastasesStage IV Rectal CancerRecurrent Rectal CancerStage IV Colon Cancer

Keywords

adult solid tumorbody system/site cancercancercolon cancercolorectal cancergastrointestinal cancergenetic conditionliver and intrahepatic biliary tract cancerliver metastasesmetastatic cancerrectal cancerrecurrent colon cancerrecurrent rectal cancersite, metastatic cancersolid tumorstage IV colon cancerstage IV rectal cancerstage, colon cancerstage, rectal cancerunclassified/other cancer

Interventions

floxuridineDRUG
leucovorin calciumDRUG
melphalanDRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsNeoplasmsColorectal NeoplasmsGastrointestinal NeoplasmsGenetic Diseases, InbornCarcinoma, HepatocellularNeoplasm Metastasis

Interventions

FloxuridineLeucovorinMelphalan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • H. Richard Alexander, Jr.

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 5, 2007

Study Start

April 1, 1999

Study Completion

March 1, 2002

Last Updated

October 31, 2023

Record last verified: 2012-03

Locations

US(1)